Research team

Centre for the Evaluation of Vaccination (CEV)

Expertise

-conduct of phase I, II, III and IV clinical trials with emphasis on vaccine trials -protocol writing -scientific writing -project management, with emphasis on infectious disease epidemiology -run the scientific secretariat of the Viral Hepatitis Prevention Board -teaching expertise in infectous diseases and vaccinology -advice to the Flemish Vaccination platform, Flanders; to the Higher Health Council, Belgium; to WHO EURO and WHO HQ

The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women. 01/01/2021 - 31/12/2024

Abstract

In view of its effectiveness to protect infants against several infectious diseases from immediately after birth, maternal immunization has gained interest in the last years. Yet, the optimal development of this vaccination strategy is still limited by the relatively poor understanding of the immunobiology of vaccine responses in pregnancy. Dynamic changes in immune function occur throughout the gestation which can impact vaccine responses in pregnant women when vaccinating at a different gestational age in pregnancy. Within this proposal, the effect of a different timing of vaccination in pregnancy on the cellular and on different aspects of the antibody-dependent immunity (titers, subclass, functionality, glycosylation) in blood will be studied. Also, the influence of this timing on the molecular basis of maternal antibody transfer across the placenta will be investigated. Additionally, a proof of concept investigating the impact of maternal vaccination and timing of maternal vaccination on breastmilk will be constructed. Within this proof of concept, quantitative and qualitative characteristics of breastmilk antibodies will be measured and an in-vitro M-cell model to measure the role of breastmilk in protecting infants from disease will be validated. Within this project, we will focus on pertussis as an example, but outcomes of this project can be applied to other infectious diseases for which vaccines can be administered in pregnancy like GBS, RSV, CMV, SARS-CoV-2…

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Research team(s)

Celluloepidemiology: generating and modeling SARS-COV-2 specific T-cell responses on a population level for more accurate interventions in public health. 01/11/2020 - 31/10/2021

Abstract

Mathematical simulation models have become indispensable tools for forecasting and studying the effectiveness of intervention strategies such as lockdowns and screening during the SARS-CoV-2 pandemic. Estimation of key modeling quantities uses the serological footprint of an infection on the host. However, although depending on the type of assay, SARS-CoV-2 antibody titers were frequently not found in young and/or asymptomatic individuals and were shown to wane after a relatively short period, especially in asymptomatic individuals. In contrast, T-cells have been found in different situations – also without antibodies being present - ranging from convalescent asymptomatic to mild SARS-CoV-2 patients and their household members, thereby indicating that T-cells offer more sensitivity to detect past exposure to SARS-CoV-2 than the detection of antibodies can. In this project, we will gather on a population level T-cell and antibody SARS-CoV-2 specific data from different well-described cohorts including 300 individuals (and 200 household members) who have had proven covid-19 infection > 3 months earlier, 100 general practitioners, 100 hospital workers, 500 randomly selected individuals and 75 pre-covid-era PBMC/sera. This data will be used in comparative simulation models and will lead to a reassessment of several key epidemiological estimates such as herd immunity and the reproduction number R that will significantly inform covid-19 related public health interventions.

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Research team(s)

PBMC service laboratory. 01/09/2020 - 31/08/2021

Abstract

In the past years the Centre for Evaluation of Vaccination (CEV) has received more and more demands of sponsors/consortia of vaccine clinical trials to collect peripheral blood mononuclear cells (PBMCs) during the clinical trial conduct. This is a consequence of the scientific communities' increasing need to evaluate not only the humoral immune response (e.g. antibodies) to vaccine exposure, but also the immune responses controlled by immune effector cells, such as specific T cells of a CD4+ helper phenotype which mediate the generation of cytotoxic T lymphocytes or the activation of innate immune effector cells. As the CEV does not have a PBMC service laboratory for isolating PBMCs, the CEV team started to collaborate in 2019 with Dr Nathalie Cools' laboratory (Laboratory for Experimental Hematology, University of Antwerp) for PBMC isolation. In the lab of Dr. Cools, 12 blood samples can be processed per day for PBMC isolation. Often there is more than 12 blood samples needed. As a consequence, our sponsors have to either reduce the subset/amount of PBMCs that are being collected during the trial conduct or they look for options outside the University of Antwerp for this service (e.g. the PBMC laboratory of the Center for vaccinology (CEVAC), University of Ghent, is able to process 30 blood samples per day for PBMC isolation). To meet the rising need of PBMC collection during vaccine clinical trials and to stay (and even become more) attractive to vaccine clinical trial sponsors/consortia, our goal is to establish a PBMC service laboratory at the CEV (CDE S2). Our initial goal is to set up a PBMC service laboratory which allows to perform 18 PBMC collections per day, while still collaborating with Dr. Cools for the same amount of samples as currently. In total, 30 PBMC collections per day could therefore be offered with this combined service. This would make the University of Antwerp more competitive with other Universities that provide this service as well (e.g. Ghent University) to perform vaccine trials for existing and future sponsors (external sources), in particular those that need a more detailed immunological analysis of responses to vaccines. In addition, it would give the CEV more independence from the laboratory of Dr. Cools, who also offers this service to other Parties (and can therefore not always assure availability). In a long term, there is also the option to increase the sample amount per day even further. Setting up the CEV PBMC service laboratory would be the first crucial step in this direction. Processing will include PBMC isolation by density gradient centrifugation, counting of viable cells and freezing of the samples. Consequently, to start up the PBMC service laboratory at the CEV, funding is needed for specific equipment (e.g. centrifuge, cell counter, cryogenic ultra-low freezer) and limited, temporary financial support for personnel. The aim is to establish a fully operational PBMC service laboratory by the end of this project. In further collaboration with Dr. Nathalie Cools' lab, a total of 30 samples a day could be processed in both labs (12 samples per lab). Once the PBMC service lab is established, the operational costs will be paid by the vaccine clinical trial sponsors/consortia.

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Research team(s)

Assessment and follow-up of SARS-Cov-2 infection in pregnant women and neonates. 01/07/2020 - 31/12/2021

Abstract

The current coronavirus pandemic affects us all. As with all infections, certain subpopulations are more vulnerable to severe disease and even death and require therefore more research. In this pandemic, the elderly and immunologically fragile people are more prone to severe disease. Pregnant women and very young infants are traditionally also considered as immunologically different from the general population, certainly in view of infectious diseases. Since little to nothing is known to the scientific world of this new virus, researchers and health care personnel dealing with pregnant women and their neonates do have concerns on the risk they run. This project offers a unique opportunity to map the impact of the current pandemic in a vulnerable subpopulation of the society. The main objective of the project is to quantify the impact of the SARSCoV- 2 pandemic in pregnant women and their newborns/infants by assessing the rate of transmission, the overall health, mental well-being, immunological responses and clinical outcomes of clinicallysuspected and laboratory-confirmed COVID-19 infections in pregnant women and their neonates. Data will be collected through online questionnaires that will be send to pregnant women at a 2 week interval until 8 weeks postpartum. This will enables us to monitor possible COVID-19 infections in pregnancy and to look at possible adverse outcomes in pregnant women, fetuses and neonates. At 12 months postpartum, women will be contacted again to look at possible long-term consequences of COVID-19 infections in pregnancy on infants. Additionally, pregnant women participating in the surveillance study will be asked to provide maternal and cord blood samples at delivery to measure the prevalence of SARS-CoV-2 specific antibodies in pregnant women and newborns and to measure the transplacental transfer of SARS-CoV-2 specific antibodies from mother to infant during pregnancy. Data from this project will be used to formulate evidence-based recommendations on prevention, treatment and vaccination for COVID-19 in pregnant women and neonates. Additionally, this project will provide information for policy makers and experts in the field on public health measures and management of pregnant women and neonates during this pandemic.

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Research team(s)

Measuring vaccination coverage in Flanders 11/05/2020 - 28/02/2022

Abstract

No abstract is available in English since this project is conducted on behalf of "Vlaams Agentschap Zorg en Gezondheid" and measures the vaccination coverage in toddlers, adolescents, pregnant women, health care workers in Flanders, Belgium.

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Research team(s)

UROSCREEN: a home-based first-void URine One-step triage option for cervical cancer SCREENing. 01/10/2019 - 30/09/2023

Abstract

Cervical cancer remains a significant problem worldwide, in Belgium, yearly over 200 women die from this disease. Almost all cervical cancer cases are caused by an infection with high risk (HR) types of the Human Papillomavirus (HPV). Traditional screening programs based on cervical smear taking (pap smear) detecting abnormal cells face numerous limitations, urging the need for alternative screening approaches. Detection of highly sensitive HR-HPV DNA in combination with more specific biomarkers such as methylation of host cell genes offer the opportunity to be detected in self-collected samples, like first-void urine. Therefore, we aim to demonstrate the clinical accuracy of HPV testing in first-void urine (WP2), in combination with triage markers (WP3). Followed by a population based pilot study to evaluate the performance of this novel screen and triage algorithm compared to self- and clinician-collected samples (WP4). And hereto offer a highly-accepted screening solution to women, especially benefitting hard-to-reach populations. And by means of this, decreasing the burden of cervical cancer associated disease and mortality.

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Research team(s)

Vaccine & Infectious Diseases Excellence in Antwerp: Infectious disease prevention, control and management in a One Health policy context (VAX-IDEA). 03/07/2019 - 31/12/2023

Abstract

Infectious diseases (ID) and antimicrobial resistance (AMR) pose a continuous and serious threat to humans and animals (One Health). Five research units from the UAntwerpen, with strong international records and collaboration, will continue to jointly capitalize on their ID expertise. EVECO studies distribution, evolution and ecology of pathogens (plague, arenaviruses, …) and wildlife hosts, offering insights for emerging ID management. LMM has established large consortia (COMBACTE, PREPARE) leading to pan-European infrastructures for ID and antimicrobial consumption research. Next to developing rapid diagnostics, LMM investigates AMR mechanisms and pathogen dynamics in vitro, in humans/livestock, and in animal models to study host-immune response (biomarker discovery) and bacterial pathogenicity. LEH performs cutting-edge research on cell-based immunotherapies, in collaboration with the UZA Center for Cell Therapy & Regenerative Medicine. LEH investigates host-immune responses in vaccine trials using multi-parametric flow cytometry and systems biology to discover novel immune correlates of protection in next-generation vaccines. CEV studies the epidemiology of vaccine-preventable diseases and performs state-of-the-art vaccine trials with large national/international networks, including maternal immunization trials and quarantine studies with genetically-modified polioviruses. Given the global need for EID vaccines (Lassa, Ebola, …) , CEV engages in several innovative (non)-human challenge-phase 1-2 studies. CHERMID undertakes methodological and applied research on the intersection between health economics, biomedicine and mathematics. CHERMID is internationally renowned for developing models of dynamic ID processes within and between hosts and integrating these with cutting edge economic models. By integrating these complementary expertises, this COE will address current and future challenges in ID management.

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Research team(s)

Vaccine for prevention and treatment of Trypanosoma cruzi infection (CRUZIVAX). 01/06/2019 - 31/05/2024

Abstract

Chagas is a neglected disease endemic in 21 Latin-American countries caused by Trypanosoma cruzi. It is the largest parasitic disease burden in the Americas (>11,000,000 chronic infections) and the first cause of cardiac morbidity in poor rural/suburban areas. It became a worldwide concern as a result of mass migration with reports in 19 nonendemic areas (>1.3 million carriers in EU/USA). Treatment is difficult since acute infections have mild symptoms and remain largely unnoticed evolving to chronicity. Drug therapy is also long, often associated with side effects (10-30% interruption) and only active during early infection. The main objective of CRUZIVAX is to bridge the gap between preclinical and clinical development by performing preclinical and clinical phase 1 studies of a needle-free vaccine against T. cruzi with proven efficacy in preclinical models. The vaccine is based on a structure-engineered trivalent chimeric antigen lacking immune decoy sequences and an adjuvant promoting self-limited locally-restricted immune activation stimulating humoral and cellular immunity, which is expected to protect as prophylactic or therapeutic (combined with Benznidazole) vaccine. To achieve this CRUZIVAX will: (i) conduct preclinical studies in mice to assess immunogenicity and efficacy of different vaccine formulations in prophylactic and therapeutic settings, (ii) analyse the immunogenicity and efficacy of the best vaccine formulation in dogs and non-human primates, (iii) produce cGMP antigen and adjuvant by cost-efficient manufacturing (facilitated uptake by health systems with limited resources), (iv) perform a preclinical safety assessment of the vaccine, (v) conduct a phase 1 vaccine clinical trial in healthy volunteers, and (vi) carry out a health economics analysis to identify critical target-product profile parameters. The vaccine will strengthen the pipeline of products for Chagas disease, aimed at reducing disease burden and its social and economic impact.

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Research team(s)

T-cell receptor diversity and AT-rich DNA sensing by glial cells as key features in controlling neurological varicella-zoster virus infections. 01/10/2018 - 30/09/2023

Abstract

Varicella-zoster virus (VZV) causes chickenpox in children and remains latent in neural ganglia afterwards. VZV reactivation causes shingles (herpes zoster, HZ). In WP1, we will prospectively recruit 150 HZ patients and 150 controls. We aim to show that the affinity of Major Histocompatibility Complex class I (MHC-I) molecules to bind VZV peptides, as needed for the development of VZV-specific Tcells, is reduced in HZ patients. Next, we will assess whether this reduced affinity leads to a reduced diversity of T-cell receptors directed against VZV, thereby implying a narrower scope of protection against VZV, or at least against several key VZV proteins. Finally, we will develop induced pluripotent stem cells (iPSC) derived sensory neurons from healthy individuals, infect these with VZV and assess whether addition of VZV-protein specific T-cells affects the control of VZV reactivation. In WP2, we aim to show that following primary VZV infection, glial cells, which are immune-responsive cells in the central nervous system, recognize VZV and subsequently produce protective cytokines. Moreover, we will assess whether mutations in AT-rich DNA sensor POL III in children with encephalitis, cerebellitis or stroke/vasculitis due to chickenpox cause a defective recognition of VZV and subsequently increased VZV proliferation in central neurons. We will do this by differentiating iPSC from patients and controls into neurons and glial cells, and subsequently infecting these with VZV.

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Vaccination during pregnancy: unravelling the basic principles. 01/10/2018 - 30/09/2021

Abstract

Despite the availability of successful universal pertussis vaccination programs, the disease remains an important global public health problem and is nowadays one of the most common vaccinepreventable diseases in the world. The highest incidence and disease burden can be found in infants below one year of age, too young to be completely protected by the currently available vaccines and vaccination schedules. To protect these vulnerable infants, alternative vaccination strategies, such as maternal vaccination, are needed. During the last years, maternal pertussis vaccination has been introduced in an increasing number of countries. Scientific evidence on different effects of this vaccination strategy has boomed during the last years. However, knowledge on several important aspects of this strategy is still lacking. Therefore, the overall aim of this research proposal is to unravel the basic principles behind the maternal (pertussis) vaccination strategy. To achieve this, eight different aims are formulated in this research proposal each looking at a different immunological aspect of the vaccination strategy. We are convinced that the results of this research proposal will not only be supportive for the current recommendation on maternal pertussis vaccination, but will also help to understand the immunological mechanisms that will be used in new vaccines that are currently under development and have the potential to be used in pregnant women like GBS, RSV, CMV, Zika….

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Research team(s)

Bringing a prophylactic Ebola vaccine to licensure (EBOVAC3). 01/06/2018 - 31/05/2023

Abstract

The overall aim of EBOVAC3 is to support an essential part of remaining clinical and manufacturing activities required for licensure in the European Union (EU) and the United States (US) of a candidate heterologous prime-boost prophylactic vaccine regimen against Ebola virus disease.

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Research team(s)

The effectiveness of the preventive measures in primary care against SARS-CoV-2 using validated, non-invasive highly sensitive serological testing 01/06/2020 - 31/05/2021

Abstract

Primary health care providers (PHCPs) like general practitioners (GPs) and their co-workers manage the vast majority of COVID-19 and other patients and keep off the pressure from hospitals. Safeguarding PHCPs' capacity during outbreaks is vital, but currently evidence is lacking on 1. how many PHCPs get infected/diseased in our country, 2. the rate at which this happens, 3. their clinical spectrum, 4. their risk factors and 5. the effectiveness of the measures to prevent this from happening. These questions need answers soon to inform policy makers. We also need more accurate (sensitive!) tests of the immune response. For this, we will evaluate a novel microfluidic dried blood spot (DBS) sampling method and digital ELISA. DBS by fingerpricking is a promising, minimally invasive and transmission safe option for blood (self-)sampling, and already applicable in a multitude of areas. In a subgroup of participants, we will compare test accuracy using the easy-to-use novel DBS method, which further minimises the potential risks of contamination and more precisely meters the required blood volume, to standard DBS.

Researcher(s)

Research team(s)

Assessment and follow-up of SARS-CoV-2 infection in pregnant women and neonates. 01/06/2020 - 31/05/2021

Abstract

The current coronavirus pandemic affects us all. As with all infections, certain subpopulations are more vulnerable to severe disease and even death and require therefore more research. In this pandemic, the elderly and immunologically fragile people are more prone to severe disease. Pregnant women and very young infants are traditionally also considered as immunologically different from the general population, certainly in view of infectious diseases. Since little to nothing is known to the scientific world of this new virus, researchers and health care personnel dealing with pregnant women and their neonates do have concerns on the risk they run. This project offers a unique opportunity to map the impact of the current pandemic in a vulnerable subpopulation of the society. The main objective of the project is to quantify the impact of the SARSCoV- 2 pandemic in pregnant women and their newborns/infants by assessing the rate of transmission, the overall health, mental well-being, immunological responses and clinical outcomes of clinicallysuspected and laboratory-confirmed COVID-19 infections in pregnant women and their neonates. Data will be collected through online questionnaires that will be send to pregnant women at a 2 week interval until 8 weeks postpartum. This will enables us to monitor possible COVID-19 infections in pregnancy and to look at possible adverse outcomes in pregnant women, fetuses and neonates. At 12 months postpartum, women will be contacted again to look at possible long-term consequences of COVID-19 infections in pregnancy on infants. Additionally, pregnant women participating in the surveillance study will be asked to provide maternal and cord blood samples at delivery to measure the prevalence of SARS-CoV-2 specific antibodies in pregnant women and newborns and to measure the transplacental transfer of SARS-CoV-2 specific antibodies from mother to infant during pregnancy. Data from this project will be used to formulate evidence-based recommendations on prevention, treatment and vaccination for COVID-19 in pregnant women and neonates. Additionally, this project will provide information for policy makers and experts in the field on public health measures and management of pregnant women and neonates during this pandemic.

Researcher(s)

Research team(s)

Een kader voor herhaalde grootschalige burgerwetenschappelijke onderzoeken om beleidsmakers snel te informeren tijdens verschillende stadia van de COVID-19-pandemie. 22/05/2020 - 21/05/2021

Abstract

In order to suppress or mitigate the COVID-19 – or any similar future - pandemic, both speed and broad population engagement are key. This project aims to collect timely information on behavioural change (voluntary or enforced by government), symptoms, workforce participation and telework, postponed treatment for non-COVID-19 related disease, as well as its psychological and social impact. We do this by setting up a large scale weekly online survey, allowing us to study evolutions over time as well as patterns in the large sets of data obtained (thus far 1 in 6 people in Flanders participated in at least one of the 6 survey waves). We use a great diversity of advanced statistical techniques to analyse the data generated, and share our insights directly with policy makers and the general public. This information directly informs policy making and partly feeds into mathematical models predicting the evolution of the pandemic under various scenarios, and can partly also be used to estimate its economic and social impact. Drawing from this experience, for future COVID-19 waves or other pandemics we aim to set up a lasting framework to obtain quickly reliable information that is representative of the general population. We also want to establish a lasting database, that enables researchers of various disciplines to use as study material in years to come.

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Research team(s)

Infradev - European Paediatric Translational Research Infrastructure (ID-EPTRI). 01/07/2019 - 30/04/2020

Abstract

The general objective of this project is to design the framework for the European Paediatric Translational Research Infrastructure (EPTRI), a new Research Infrastructure (RI) aimed to enhance technology-driven paediatric research in discovery and early development phases to be translated into clinical research and paediatric use of medicines. The starting point of the proposal is the serious lack of medicines for children in EU and worldwide as well as the lack of a developmental model for paediatric medicines that integrates technology-driven aspects with the methodological, ethical and regulatory framework. The design for this new RI will be based on the following main pillars: • to harness efficiency and delivery of paediatric research activities and services strengthening collaboration within the scientific paediatric community; • to be a complementary RI in the context of the existing RIs covering the current gaps, while avoiding any duplication; • to develop a one-stop-shop for advice in paediatric drug development. To prepare a valuable Conceptual Design Report (CDR), the project encompasses three phases. During the Context Analysis phase, that will be performed in 5 technical and scientific domains (1- Paediatric Medicines Discovery, 2- Paediatric Biomarkers and Biosamples, 3-Developmental Pharmacology, 4-Paediatric Medicines Formulations and Medical Devices, 5- Underpinning Medicines Development to Paediatric Clinical Studies) the perceived value and the possible gaps to be covered will be estimated by enquiring the scientific communities and many other Stakeholders. During the Operational phase, the different components of the new RI will be depicted including governance model strategies for interaction with national Authorities and the existing RIs, the IT-architecture model, services to be provided and a business plan. Finally, a Feasibility phase is proposed to develop virtual exercises simulating the operations of the RI. The final result of the project will be the CDR to realize EPTRI.

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Research team(s)

Assessment of the nasopharyngeal carriage of Streptococcus pneumoniae and other common pathogens in infants (6-30 months) with acute otitis media and in healthy infants (6-30 months) attending day-care centres in Belgium 01/10/2018 - 14/09/2020

Abstract

General use of vaccines against Streptococcus pneumoniae (S. pneumoniae) in infants has led to a decrease in the presence of the serotypes against which the vaccine was developed. It is a pathogen of which more than 90 different serotypes exist, of whom 10 to 13 are covered by the current vaccines. In order to gain a clear understanding of the S. pneumoniae serotypes carried by infants, and the impact of the vaccine used in the vaccination program, the current study was set up. As early as the first months of our lives S. pneumoniae is present in the nasal cavity and in the pharynx, mostly only temporary and innocuous, yet in some cases, in infants it may lead to infections such as otitis, pneumonia or meningitis. Since the presence of S. pneumoniae is more abundant in some circumstances, the current study focuses on infants between the age of 6 and 30 months either healthy and residing in day-care centres or suffering from an acute middle ear infection. Over a 4 year period, a swab will be taken from the nasal cavity of these infants (700 in first year, 900 in subsequent years, 6800 in total) to investigate presence, density and type of S. pneumoniae carriage, if any, as well as its resistance against antibiotics. The presence of some other pathogens that can cause airway or ear infections will be investigated too. The findings of this study will be extremely valuable to guide decisions on vaccine development, vaccine program, and recommendations on antibiotic treatment.

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Research team(s)

Scientific Chair "International Collen-Francqui 2018-2019" (Prof. dr. Philippe De Wals). 01/10/2018 - 30/09/2019

Abstract

Deze Franqui chair is occupied by Prof Philippe De Wals, Professor at the Laval University in Quebec, Canada. The subject is immunisation programs. During his stay he will convene a "Class of Excellence", selected from different universities. At the end of his stay there will be a symposium at UAntwerpen, with collaboration of this "Class of Excellence".

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Research team(s)

Biomarkers in first-void urine for improved diagnosis and monitoring of cervical (pre)cancer. 01/10/2017 - 30/09/2019

Abstract

Cervical cancer remains a significant problem worldwide, in Belgium, yearly over 200 women die from this disease. Almost all cervical cancer cases are caused by an infection with high-risk (hr) types of the Human Papillomavirus (HPV). Traditional screening programs based on cervical smear taking (pap smear) detecting abnormal cells face numerous limitations, urging the need for alternative screening approaches. Detection of hrHPV DNA instead of abnormal cervical cells has proven more sensitive in detecting cervical cancer cases, however, it lacks clinical specificity, i.e. the ability to detect solely those women who require follow-up or immediate referral for colposcopy. Therefore, the major objective of this study is to analyse candidate biomarkers for diagnosis of cervical (pre)cancer and disease monitoring in home-collected first-void (FV) urine samples, followed by translation of the presence of (1) hrHPV DNA and (2) these biomarkers into a novel screening algorithm for cervical cancer. Hereto, we will conduct two clinical trial studies, where women (=30 years) diagnosed with an abnormal pap smear will be asked to provide a FV morning urine sample. In the first study, we aim to identify accurate biomarkers for respectively low-, and high-grade squamous intraepithelial lesions. In a second study, multiple samples will be collected over time (longitudinal sample collection) to identify biomarkers that can predict pro- or regression of HPV infection/precancerous lesions.

Researcher(s)

Research team(s)

Assessment of the nasopharyngeal carriage of Streptococcus pneumoniae and other common pathogens in infants (6-30 months) with acute otitis media and in healthy infants (6-30 months) attending day-care centres in Belgium. 01/10/2016 - 30/09/2018

Abstract

General use of vaccines against Streptococcus pneumoniae (S. pneumoniae) in infants has led to a decrease in the presence of the serotypes against which the vaccine was developed. It is a pathogen of which more than 90 different serotypes exist, of whom 10 to 13 are covered by the current vaccines. In order to gain a clear understanding of the S. pneumoniae serotypes carried by infants, and the impact of the vaccine used in the vaccination program, the current study was set up. As early as the first months of our lives S. pneumoniae is present in the nasal cavity and in the pharynx, mostly only temporary and innocuous, yet in some cases, in infants it may lead to infections such as otitis, pneumonia or meningitis. Since the presence of S. pneumoniae is more abundant in some circumstances, the current study focuses on infants between the age of 6 and 30 months either healthy and residing in day-care centres or suffering from an acute middle ear infection. Over a 4 year period, a swab will be taken from the nasal cavity of these infants (700 in first year, 900 in subsequent years, 6800 in total) to investigate presence, density and type of S. pneumoniae carriage, if any, as well as its resistance against antibiotics. The presence of some other pathogens that can cause airway or ear infections will be investigated too. The findings of this study will be extremely valuable to guide decisions on vaccine development, vaccine program, and recommendations on antibiotic treatment.

Researcher(s)

Research team(s)

    Vaccination coverage in Flanders, 2016 13/11/2015 - 31/12/2016

    Abstract

    This is a survey to assess vaccination coverage in infants (18-24 months), adolescents and mothers during pregnancy in Flanders. At home interviews to collect data on vaccination status and reasons for non-vaccination as well as attitudes towards vaccination are performed in a two-stage cluster sample of 875 infants, 1250 adolescents and 625 mothers who delivered less than three monts before. Vaccination data found at home are completed with vaccination data from physicians and Vaccinnet, the central registry. This study is a collaboration between CEV(UAntwerp) and KULeuven (LUVAC), and ordered by the Flemish government.

    Researcher(s)

    Research team(s)

      Biomarkers in first-void urine for improved diagnosis and monitoring 01/10/2015 - 30/09/2018

      Abstract

      Advantages of urine as clinical sample – non-invasive, through self-collection, and at-home collection – are well accepted. However, the use of (first-void) urine as source of biomarkers for diseases of the urinary genital track is much less explored. This project will demonstrate the value of (first-void) urine as liquid biopsy for diagnosis of cervical (pre)cancer lesions, determining progression of HPV infection, and defining immunity towards HPV infection.

      Researcher(s)

      Research team(s)

        Biomarkers in first-void urine for improved diagnosis and monitoring of cervical (pre)cancer. 01/10/2015 - 30/09/2017

        Abstract

        Cervical cancer remains a significant problem worldwide, in Belgium, yearly over 200 women die from this disease. Almost all cervical cancer cases are caused by an infection with high-risk (hr) types of the Human Papillomavirus (HPV). Traditional screening programs based on cervical smear taking (pap smear) detecting abnormal cells face numerous limitations, urging the need for alternative screening approaches. Detection of hrHPV DNA instead of abnormal cervical cells has proven more sensitive in detecting cervical cancer cases, however, it lacks clinical specificity, i.e. the ability to detect solely those women who require follow-up or immediate referral for colposcopy. Therefore, the major objective of this study is to analyse candidate biomarkers for diagnosis of cervical (pre)cancer and disease monitoring in home-collected first-void (FV) urine samples, followed by translation of the presence of (1) hrHPV DNA and (2) these biomarkers into a novel screening algorithm for cervical cancer. Hereto, we will conduct two clinical trial studies, where women (=30 years) diagnosed with an abnormal pap smear will be asked to provide a FV morning urine sample. In the first study, we aim to identify accurate biomarkers for respectively low-, and high-grade squamous intraepithelial lesions. In a second study, multiple samples will be collected over time (longitudinal sample collection) to identify biomarkers that can predict pro- or regression of HPV infection/precancerous lesions.

        Researcher(s)

        Research team(s)

          Gene expression analyses for the differentiation between viral and bacterial meningitis in children. 01/07/2015 - 30/06/2017

          Abstract

          Rapid detection of bacterial meningitis in children remains an important goal for emergency room doctors and paediatricians. The differentiation between viral and bacterial meningitis in children is mainly based on clinical scoring systems that are, however, neither 100% sensitive nor 100% specific. Additionally, adequate sampling of cerebrospinal fluid (CSF) is not always achievable. Recently, the value of gene expression analyses for infectious diseases has been illustrated in several clinical and experimental settings. Several studies were able to show a difference in gene expression between different types of influenza, between different types of bacterial infections, between tuberculosis and other inflammatory or infectious diseases in African children and between some viral infections and some bacterial infections. However, none of these studies specifically addressed the value of gene expression analyses in differentiating between viral and bacterial meningitis. In this multicentre prospective study, we will use whole blood gene expression analyses to differentiate between viral and bacterial infections in children with meningitis (N = 80). This study will add to the important clinical differentiation between viral and bacterial meningitis in children. Furthermore, we believe that the determination of the gene expression signalling in bacterial (but also viral) meningitis will elucidate the pathophysiology of this disease.

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          Research team(s)

            Planning support for phase I study with n-OPV2. 17/06/2015 - 25/09/2015

            Abstract

            This project represents a formal research agreement between UA and on the other hand the client. UA provides the client research results mentioned in the title of the project under the conditions as stipulated in this contract.

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            Research team(s)

              Multidisciplinary research on vaccination and infectious diseases (Vaxinfectio-PO). 01/01/2015 - 31/12/2020

              Abstract

              Integrated vaccine and microbiological research with a focus on increasing the understanding of the immune response in prophylactic and therapeutic vaccines (including tumour vaccines) and on the containment of antibiotic resistance. Several innovative research topics are ongoing or in the pipeline: potential development of theranostic devices (e.g. rapid Point of Care Diagnostics, optical biosensors, lab-on-chip, microarrays) for pathogen detection and associated resistance in collaboration with several European research partners; potential development of new rapid diagnostic tests and injection devices; potential development of patient-specific cellular vaccines for targeted antiviral and anticancer therapy.

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              Research team(s)

              ASCID: Antwerp Study Centre for Infectious Diseases. 01/01/2015 - 31/12/2019

              Abstract

              This project represents a research contract awarded by the University of Antwerp. The supervisor provides the Antwerp University research mentioned in the title of the project under the conditions stipulated by the university.

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              Research team(s)

              Predicting Immune responses by Modeling immunoSequencing data (PIMS). 01/01/2015 - 31/12/2018

              Abstract

              Vaccine trials study the changes in vaccine-induced antibodies and T-cells and their protective value against natural infection. As such it has been noted that not all vaccines are equally effective and that variability exists between individuals in the magnitude and duration of the immune response after vaccination. We hypothesize that individual-specific genetic characteristics collected in a short time-window after vaccination are sufficient to predict immune responses for a long time period after vaccination. In this project we will recruit 120 individuals: 40 individuals will receive de novo and booster hepatitis B vaccination, 40 individuals will receive a monovalent measles booster vaccine and 40 individuals will receive a combined measles-mumps-rubella booster vaccine. The participants will undergo sampling on different time points (up to one year after vaccination). We will assess the changes in the expression of genes (transcriptomics) in immune-competent cells following vaccination, the individual-specific genetic predisposition for peptide recognition by T-cells (T-cell receptor and major histocompatibility sequencing), and adaptive immune responses (peptide-specific T-cells, antibodies) after vaccination. We will use advanced longitudinal modeling, data mining and machine learning techniques that will allow us to predict T-cell responses by means of the collected individual-specific data over long time periods. Through this project we will set the standard for Next-Generation Vaccinology. Importantly, our results will also be applicable to other fields of research such as therapeutic cancer vaccination and viral immunology.

              Researcher(s)

              Research team(s)

                Project website

                Pertussis immunization during pregnancy: assessment of the role of maternal antibodies on immune responses in term and preterm infants: the MAMA study. 01/01/2015 - 31/12/2018

                Abstract

                The present study aims to give an answer on the lack of knowledge on immune responses in young infants (term and preterm born) to pertussis vaccines in the presence of high titers of maternal antibodies, induced by vaccination during pregnancy.

                Researcher(s)

                Research team(s)

                  Assessment of the Neonatal hepatitis B vaccination Coverage & Attitude in the Mekong delta (ANBeCAM). 01/09/2014 - 31/08/2016

                  Abstract

                  The current ANBeCAM project envisages to set up a new partnership between Can Tho University of Medicine and Pharamacy (Vietnam) and UAntwerpen to assess the neonatal hepatititis B vaccine coverage in the region and identify possible solutions to increase the coverage.

                  Researcher(s)

                  Research team(s)

                    Gastroenteritis in rotavirus vaccinated infants in Belgium and Vietnam: the effect of maternal antibodies through breastfeeding and the identification of (new) pathogens. 01/01/2014 - 31/12/2015

                    Abstract

                    This is a fundamental research project financed by the Research Foundation – Flanders (FWO). The project was subsidized after selection by the FWO-expert panel. The objective of the FWO's Research projects is to advance fundamental scientific research.

                    Researcher(s)

                    Research team(s)

                      Bioactive components in human milk. 01/01/2014 - 31/12/2014

                      Abstract

                      The effect of vaccination during pregnancy on bioactive components in breast milk (antibodies against pertussis and influenza, the total amount of SIgA and its subclasses and lactoferrin) will be examined. In addition, we will study the influence of storage conditions on the bioactive components. The differences between breast milk from mothers of preterm and term infants will be investigated in cooperation with the department of Neonatology at UZA.

                      Researcher(s)

                      Research team(s)

                      The effect of pertussis vaccination during pregnancy. 01/10/2013 - 30/11/2016

                      Abstract

                      The present project aims to investigate the immunological effects of maternal pertussis vaccination during pregnancy in both women and infants in order to provide scientific evidence for the beneficial protective effect of maternal vaccination in both woman and infant. This will be conducted in 2 countries with different epidemiological conditions and vaccines (Belgium & Vietnam).

                      Researcher(s)

                      Research team(s)

                        A quantitative analysis of varicella-zoster virus infection: from immunology to epidemiology. 01/10/2013 - 31/07/2015

                        Abstract

                        It is our goal to conceptualise mathematical models that describe the basic immunology with regard to varicella-zoster virus (VZV) and immunological perturbations caused by VZV at the individual level. Furthermore, at the population based level we will formulate mathematical models describing the transmission of VZV between individuals. Simulations of both withinhuman and between-human dynamics will be based on biological and epidemiological parameters. These parameters will be estimated from our previous studies, and other international studies, as well as this project's experimental study, which is designed to provide major insights in the immunology of latency and reactivation. More specifically, we will longitudinally assess the immune response of about 120 VZV immune persons whose immune systems were recently perturbed for different reasons such as re-exposure to VZV and reactivation of VZV as shingles (Herpes Zoster). In an innovating way we will also perform similar analyses in 30 healthy individuals thereby creating a control group and defining a benchmark for longitudinal variation in immunity. The biological parameters will be implemented in our newly developed mathematical models after thorough statistical analysis. For the first time in this field, we will apply certain advanced statistical techniques (nonlinear mixed and growth mixture models).

                        Researcher(s)

                        Research team(s)

                          Optimized detection of infectious diseases of the oral cavity by NA based assays using an improved, safe and user-friendly mouthwash.d.m 01/08/2013 - 31/07/2015

                          Abstract

                          Sampling of the oral cavity for the detection of infectious agents is possible via a mouth wash instead of a cyto-bruch or a wiper. During this project an in-house developed mouth wash will be tested.

                          Researcher(s)

                          Research team(s)

                            Monitoring the impact of HPV vaccination through surveys of HPV DNA prevalence in urine samples from adolescents. 01/07/2013 - 31/07/2018

                            Abstract

                            This project represents a formal research agreement between UA and on the other hand IARC-WHO. UA provides IARC-WHO research results mentioned in the title of the project under the conditions as stipulated in this contract.

                            Researcher(s)

                            Research team(s)

                              Investigation of a new medical device with guaranteed collection of first fraction urine for the detection of human papilloma virus (COLLI-PEE). 01/07/2013 - 30/06/2014

                              Abstract

                              This project represents a formal research agreement between UA and on the other hand Novosanis. UA provides Novosanis research results mentioned in the title of the project under the conditions as stipulated in this contract. Vaxinfectio took care of clinical investigations and Product Development took care of the optimization of usability aspects. The project received the IWT-award 2015 in the category societal relevance.

                              Researcher(s)

                              Research team(s)

                                Seroprevalention 2012. 13/12/2012 - 31/12/2012

                                Abstract

                                This project represents a formal research agreement between UA and on the other hand WIV. UA provides WIV research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                Researcher(s)

                                Research team(s)

                                  The role of CMV-infection in age-related hyporesponsiveness to influenza vaccination. 01/10/2012 - 30/09/2015

                                  Abstract

                                  It is expected that worldwide in fewer than 10 years the population over the age of 65 will outnumber the population of children under the age of 5 for the first time in history. While it is generally accepted that ageing is associated with immune dysfunction and dysregulation (i.e. immunosenescence), it has been suggested that this immune deterioration might be correlated with persistent cytomegalovirus infection (CMV). We investigate the association between persistent CMV infection and immunosenescence in frail elderly living in nursing homes focusing on the humoral and cellular responsiveness to influenza vaccination. Results will be compared with findings in community-dwelling age-mates through a collaborative project. As outcome of this research we expect to identify yet unknown mechanisms involved in immunosenescence and to unravel its association with CMV infection. This knowledge will ultimately contribute to new prevention strategies which might include pre-vaccination screening, aiming a more effective response in an individual whose immune system is in decline.

                                  Researcher(s)

                                  Research team(s)

                                    Reducing the burden of Pertussis disease in very young infants in different epidemiological settings by augmenting maternal antibody concentrations during pregnancy. 01/06/2012 - 31/05/2014

                                    Abstract

                                    Worldwide current Pertussis immunization strategies fail to protect infants younger than 2 months, the starting age of a primary immunization schedule. These infants are prone to severe Pertussis, in developing as weil as in industrialized countries, with fatal consequences (300,000 deathsjyear worldwide). In countries with Pertussis vaccination programs, young adults become susceptible due to waning immunity and are source of infection for infants. Different strategies are evaluated to overcome this problem: cocoon vaccination, maternal vaccination, and neonatal vaccination. The present South Initiative aims to close the susceptibility gap between birth and administration of a primary series of vaccines, by maternal vaccination, thus increasing maternal antibodies in very young infants up to the age of 2 months. This will be conducted in two countries with different epidemiological conditions. The potential interference of maternal antibodies on the vaccine response in the children will be measured until the age of 15 months. This study methodology is unique in the world.

                                    Researcher(s)

                                    Research team(s)

                                      Study of vaccination coverage in Flanders in 2012. 04/01/2012 - 31/01/2013

                                      Abstract

                                      This project represents a formal research agreement between UA and on the other hand Vlaams Agentschap Z&G. UA provides Vlaams Agentschap Z&G research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                      Researcher(s)

                                      Research team(s)

                                        Quantification of varicella-zoster virus boosting mechanisms with their public health implications for vaccination. 01/01/2012 - 31/12/2014

                                        Abstract

                                        The general aim is (1) to quantify exogenous boosting by means of an observational longitudinal study, (2) implement this result in newly adapted epidemiological models, (3) assess the population effects of vaccination against VZV and (4) apply this to inform a cost-utility analysis examining vaccination against VZV.

                                        Researcher(s)

                                        Research team(s)

                                          Reducing the burden of Pertussis disease in very young infants in different epidemiological settings through pertussis vaccination in pregnancy. 01/01/2012 - 31/12/2013

                                          Abstract

                                          Current pertussis immunization strategies fail to protect infants, too young to be immunized. The aim of the study is to measure the influence of a pertussis booster dose during pregnancy, on the titer and duration of maternal antibodies in neonates. Early life humoral immunity and the influence on vaccine response of the infant will be assessed. Conducting the study in parallel in an industrialized and a country in transition offers a unique opportunity to compare vaccination strategies in different epidemiologic settings and with different vaccination programs. The study will be instrumental for further safety, immunogenicity, efficacy and field effectiveness studies.

                                          Researcher(s)

                                          Research team(s)

                                            A quantitative analysis of varicella-zoster virus infection: from immunology to epidemiology. 01/10/2011 - 30/09/2013

                                            Abstract

                                            It is our goal to conceptualise mathematical models that describe the basic immunology with regard to varicella-zoster virus (VZV) and immunological perturbations caused by VZV at the individual level. Furthermore, at the population based level we will formulate mathematical models describing the transmission of VZV between individuals. Simulations of both withinhuman and between-human dynamics will be based on biological and epidemiological parameters. These parameters will be estimated from our previous studies, and other international studies, as well as this project's experimental study, which is designed to provide major insights in the immunology of latency and reactivation. More specifically, we will longitudinally assess the immune response of about 120 VZV immune persons whose immune systems were recently perturbed for different reasons such as re-exposure to VZV and reactivation of VZV as shingles (Herpes Zoster). In an innovating way we will also perform similar analyses in 30 healthy individuals thereby creating a control group and defining a benchmark for longitudinal variation in immunity. The biological parameters will be implemented in our newly developed mathematical models after thorough statistical analysis. For the first time in this field, we will apply certain advanced statistical techniques (nonlinear mixed and growth mixture models).

                                            Researcher(s)

                                            Research team(s)

                                              Development and implementation of a curriculum for an interactive training course on vaccinology. 27/05/2011 - 15/08/2011

                                              Abstract

                                              This project represents a formal service agreement between UA and on the other hand WHO. UA provides WHO research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                              Researcher(s)

                                              Research team(s)

                                                Development of Module for the Immunological Basis for Immunization Series on Hepatitis B. 31/01/2011 - 04/02/2011

                                                Abstract

                                                This project represents a formal service agreement between UA and on the other hand the World Health Organization (WHO). UA provides the World Health Organization (WHO) the research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                                Researcher(s)

                                                Research team(s)

                                                  Efficiency, equity and autonomy: the ethics of vaccination policy. 01/01/2011 - 31/12/2014

                                                  Abstract

                                                  We aim to investigate the ethical justifiability of different vaccine policy options. Vaccines are credited with having saved more lives than any other medical technology. Their distribution is of critical importance to guarantee a fair equality of opportunity to everyone. We distinguish three different but possibly conflicting ethical values that constitute just vaccination programs: efficiency, equity and autonomy. Cost-effective vaccines must guarantee as much health as possible given the budget constraint. However the distribution of the financial and medical burdens and benefits of vaccination programs in a population should also be equitable. Since the burdens and benefits of vaccination do not remain limited to the vaccinated person, distributive justice is more complex to determine, compared to other health products and services. Moreover the social dimension of vaccination also creates tension between individual rights and societal duties.

                                                  Researcher(s)

                                                  Research team(s)

                                                    What explains socio-economic differences in health behaviour? Vaccination of children. 01/10/2010 - 30/09/2013

                                                    Abstract

                                                    The aim of this project is to gain insight in the mechanisms underlying socio-economic differences in health seeking behavior, with a focus on vaccination behavior. Throughout the work, I integrate theories from different social sciences (sociology, economics, (social) psychology, and administrative sciences). I aim to contribute to the scientific knowledge on both vaccination behavior in general (identifying factors explaining this behavior can offer keys to the understanding of differences in the behavior) and on socio-economic differences in this behavior (where possible I want to directly observe these differences and connect them to underlying mechanisms).

                                                    Researcher(s)

                                                    Research team(s)

                                                    Maternal Antibodies against Mumps in a Cohort of children up to the age of 1 year. 31/01/2010 - 30/11/2010

                                                    Abstract

                                                    The present project will measure the amount of mumps antibodies in childhearing women and the duration of the presence of these mumps antibodies in their infants. The titer of anti-mumps antibodies in the women will depend on the vaccination status, the waning of the antibodies and the eventual boosters by wild type virus. The titer of passively acquired mumps antibodies will be determined by the titer in the mother.

                                                    Researcher(s)

                                                    Research team(s)

                                                      Kosteneffectiviteit van 7, 10 en 13-valente pneumokokken conjugaat vaccin 2009-52_HTA. 10/12/2009 - 15/04/2011

                                                      Abstract

                                                      The aims of this project are to estimate - by means of simulation models - the effectiveness and costeffectiveness of various options of use of licensed 7,10 and 13 valent pneumococcal conjugate vaccines (PCV) vaccines in Belgium, taking account of the Belgian and international experience with these vaccines in terms of efficacy, safety and postlicensure effectiveness. These estimates should include herd immunity effects, serotype replacement effects, and where possible the indirect effects of vaccination on cross protection and antimicrobial resistance.

                                                      Researcher(s)

                                                      Research team(s)

                                                        Multidisciplinary research on vaccination and infectious diseases. 01/11/2009 - 31/12/2014

                                                        Abstract

                                                        Integrated vaccine and microbiological research with a focus on increasing the understanding of the immune response in prophylactic and therapeutic vaccines (including tumour vaccines) and on the containment of antibiotic resistance. Several innovative research topics are ongoing or in the pipeline: potential development of theranostic devices (e.g. rapid Point of Care Diagnostics, optical biosensors, lab-on-chip, microarrays) for pathogen detection and associated resistance in collaboration with several European research partners; potential development of new rapid diagnostic tests and injection devices; potential development of patient-specific cellular vaccines for targeted antiviral and anticancer therapy.

                                                        Researcher(s)

                                                        Research team(s)

                                                          Project website

                                                          Scientific chair "Advanced research and development in addiction medicine & psychiatry". 01/01/2009 - 31/12/2014

                                                          Abstract

                                                          This project represents a formal research agreement between UA and on the other hand a private institution. UA provides the private institution research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                                          Researcher(s)

                                                          Research team(s)

                                                          Infectious disease models: wildlife ecology, ecological disturbance and transmission to humans. 01/01/2009 - 31/12/2012

                                                          Abstract

                                                          Changing environmental conditions (e.g. climate) are likely to affect the ecology of infections, through changes in the abundance of susceptible natural host populations or by affecting transmission rates (directly or through vectors). This project investigates these effects, through observations, experiments and mathematical modelling, for five model infections selected for their different characteristics (hantaviruses in voles, plague in gerbils, arenavirus in African mice, dengue fever in humans, rotaviruses in vaccinated humans). The insights are used to evaluate potential changes in burden of disease, with or without control measures.

                                                          Researcher(s)

                                                          Research team(s)

                                                          Drug use among female sex workers in Belgium (DRUSEB). 01/10/2008 - 31/12/2011

                                                          Abstract

                                                          This project represents a formal research agreement between UA and on the other hand the Federal Public Service. UA provides the Federal Public Service research results mentioned in the title of the project under the conditions as stipulated in this contract.

                                                          Researcher(s)

                                                          Research team(s)

                                                            What explains socio-economic differences in health behaviour? Vaccination of children. 01/10/2008 - 30/09/2010

                                                            Abstract

                                                            The aim of this project is to gain insight in the mechanisms underlying socio-economic differences in health seeking behavior, with a focus on vaccination behavior. Throughout the work, I integrate theories from different social sciences (sociology, economics, (social) psychology, and administrative sciences). I aim to contribute to the scientific knowledge on both vaccination behavior in general (identifying factors explaining this behavior can offer keys to the understanding of differences in the behavior) and on socio-economic differences in this behavior (where possible I want to directly observe these differences and connect them to underlying mechanisms).

                                                            Researcher(s)

                                                            Research team(s)

                                                            Integrated vaccine and infectious disease research. 01/01/2008 - 31/12/2014

                                                            Abstract

                                                            The prevention and treatment of bacterial and viral infections are the main focus of the Methusalem project VAXINFECTIO. Antibiotic resistance, anti-tumoral and antiviral cellular immune responses by dendritic cells, the evaluation of vaccination, and the socio-economic aspects of the use of vaccines and antibiotics are research topics that will be addressed. The Vaccine & Infectious Disease Instituut (VAXINFECTIO) of the Universiteit Antwerpen - consisting of the Laboratory of Medical Microbiology (LMM), the Laboratory of Experimental Hematology (LEH) and the Centre for the Evaluation of Vaccination (CEV) - maintains a close collaboration with the Centre for Statistics (CenStat) of the Universiteit Hasselt.

                                                            Researcher(s)

                                                            Research team(s)

                                                              Project website

                                                              Health Economics Research and Mathematical Modelling of Infectious Diseases. 01/12/2007 - 31/12/2014

                                                              Abstract

                                                              The research plan over the next years involves four main research themes: 1.1.Modelling infectious diseases; 1.2.Data collection and analysis for burden of (infectious) disease estimates; 1.3.Program evaluations of infectious disease interventions; 1.4.Health economics and program evaluations in general. Each of these research themes departs from the observation that the current methodological approach can be substantially improved by using more sophisticated methods. Since these research themes are each multidisciplinary and interconnected, these improvements are expected to occur within each theme and over all themes combined.

                                                              Researcher(s)

                                                              Research team(s)

                                                                Creation of a translational platform for integrated vaccine research. 01/12/2007 - 26/11/2012

                                                                Abstract

                                                                The aim of the project is to develop a translational platform for integrated vaccine research, building upon the expertise of the Vaccine and Infectious Diseases Institute as regards the set-up and implementation of vaccine trials (phase I-IV), microbiological diagnostics and basic immunological research. This platform will operate according to ISO standards, and thanks to a swift transition from lab to 'bed-side', and to a swift feedback from bed-side to lab, will guarantee a fast development of a new generation of HPV vaccines. This platform will create the opportunity, in collaboration with the industrial partner, to develop serological and urine tests for early efficacy testing and follow-up of vaccinees. In addition, basic research into the mucosal cellular immunity can be initiated within this cooperation structure. The financial input of this project will allow the Institute to consolidate the available knowledge of HPV-testing and to further develop this knowledge with a clear focus on economic valorisation; furthermore, the existing collaboration with the pharmaceutical industry will get an additional dimension with new opportunities of expansion and collaboration.

                                                                Researcher(s)

                                                                Research team(s)

                                                                  Study of vaccination coverage in children and adolescents in Flanders in 2008. 01/12/2007 - 31/12/2008

                                                                  Abstract

                                                                  Vaccination coverage of recommended infant vaccins in Flemish toddlers at 18-24 months-of-age and evaluation of risk factors for undervaccination, as part of the Vaccination Coverage study in infants and adolescents in 2008 funded by the Flemish Government. In partnership with the KULeuven, till end 2008.

                                                                  Researcher(s)

                                                                  Research team(s)

                                                                    Has the time to control Hepatitis A globally? 01/06/2007 - 31/05/2008

                                                                    Abstract

                                                                    Researcher(s)

                                                                    Research team(s)

                                                                      Economic evaluation of rotavirus immunisation of infants in Belgium. 01/12/2006 - 31/05/2007

                                                                      Abstract

                                                                      In this report, a simulation model was used to help understand the implications of deciding on the use of the currently available oral rotavirus vaccines (Rotarix® and RotaTeq®) to our greatest advantage. In health economic evaluation, as applied in this report, what is to our society's greatest advantage is defined as the combination of interventions leading to the greatest possible health gains, for as many people as possible (i.e. maximization of health gains (expressed here mainly as life years and Quality-Adjusted Life-Years (QALYs gained)), under a given budget constraint. We have reviewed the international published and unpublished literature, and collected and analyzed a wide range of Belgian epidemiological and cost data. A simulation model was developed, parameterized and fitted by using scientifically validated data, as much as possible from Belgian sources. Simulations were performed to estimate how effective and cost-effective universal rotavirus vaccination of Belgian children would be.

                                                                      Researcher(s)

                                                                      Research team(s)

                                                                        Project website

                                                                        Duration of vaccine-induced protection against hepatitis B: detailed mathematical modelling of long-term data from vaccinated persons, evaluating the influencing factors and the correlation between humoral and cellular immune responses. 01/10/2006 - 30/09/2009

                                                                        Abstract

                                                                        Researcher(s)

                                                                        Research team(s)

                                                                          Prevalence of maternal antibodies against vaccine preventable infections: sero-epidemiological survey of antibody concentrations in women in third trimester of pregnancy; comparison between vaccinated mothers and mothers with natural immunity. 01/03/2006 - 31/12/2007

                                                                          Abstract

                                                                          This pilot study aims to measure the prevalence of antibodies against vaccine-preventable diseases in pregnant women as well as the feasibility of a larger study in pregnant women and their off springs. A first group consists of pregnant women who have been immunized for measles, rubella, or eventually hepatitis A and a second group of women who acquired the infection naturally. The prevalence of maternal antibodies against infections for which there are currently no universal vaccination programmes (CMV, rota-virus and varicella), is meaningful for the comparison with potential future immunized cohorts of women. The feasibility of collecting samples and vaccination data is one of the main aspects of this pilot study.

                                                                          Researcher(s)

                                                                          Research team(s)

                                                                            The immunological basis for immunization series on hepatitis B. 15/11/2005 - 15/11/2006

                                                                            Abstract

                                                                            Researcher(s)

                                                                            Research team(s)

                                                                              Effective and acceptable strategies for the control of SARS and new emerging infections in China and Europe (SARSControl). 01/01/2005 - 31/03/2008

                                                                              Abstract

                                                                              Researcher(s)

                                                                              Research team(s)

                                                                                Study of vaccination coverage in infants, children and adolescents in Flanders, 2004. 01/12/2004 - 31/12/2005

                                                                                Abstract

                                                                                To obtain efficient control of infectious disease, surveillance of vaccination data is necessary. As the data from registration by the organized preventive services are not complete, in 2000 a first survey was made on a representative sample of the infant population between 18 and 24 months age to obtain the vaccination coverage in 1999. This survey will be repeated in 2005,and expanded to 7-years-olds and adolescents, to know the actual situation and to detect evolutions. A sample of 3700 children will be questioned about their vaccination status. Moreover, distinctive features of non or uncompletely vaccinated children will be looked for, to be able to deduce recommendations for vaccination policy in Flanders.

                                                                                Researcher(s)

                                                                                Research team(s)

                                                                                  Improving Public Health Policy in Europe through Modelling and Economic Evaluation of Interventions for the Control of Infectious Diseases. (POLYMOD) 01/09/2004 - 31/08/2008

                                                                                  Abstract

                                                                                  This international EU project aims to optimise the methods for modelling and economic evaluation of interventions for the control of infectious diseases (particularly vaccination). New information on how people mix socially, and how this contributes to the spread of infectious disease in Europe, will be assembled and used optimally in dynamic mathematical simulation models. These techniques will be applied to specific interventions in combination with economic evalauation. The results of these analyses will be made directly available to policy makers in 15 European countries.

                                                                                  Researcher(s)

                                                                                  Research team(s)

                                                                                    Statistical properties of the force of infection, the contact matrix and the reproduction rate : estimation, interrelation and impact on mathematical models for the dynamic transmission of infectious diseases. 01/01/2004 - 31/12/2009

                                                                                    Abstract

                                                                                    Research on contact matrices play a crucial role in the mathematic modelling of infectious diseases. Up to now only a limited number of studies to quantify the contact patterns between humans have been conducted. Aim of the study is to estimate contact matrices through a diary survey in a random sample, and relate these data to the estimated force of infection for certain vaccine preventable infections (based on sero-epidemiological data).

                                                                                    Researcher(s)

                                                                                    Research team(s)

                                                                                      A phase II, prospective, randomized, double-blind, placebo, controlled trial to assess the safety and tolerability of influenza virus vaccine, trivalent, types A and B live cold-adapted liquid formulation (CAIV-T) in healthy children and adolescents. 25/06/2003 - 30/08/2003

                                                                                      Abstract

                                                                                      In this multicentric study 240 healthy subjects (45 in our center) will receive 1 dose of either the candidate flu-vaccine, either placebo, both conditioned as a nasal spray. The virus strains contained in the flu vaccine are those recommended by the WHO for the winter 2003-2004. Safety will be assessed during 7 consecutive days starting on the day of vaccination. A last phone call will be made 21 days after vaccination to report serious adverse events.

                                                                                      Researcher(s)

                                                                                      Research team(s)

                                                                                        Screening programme for sexually transmitted infections and hepatitis B vaccination of sex workers in the province of Antwerp. 01/01/2003 - 31/12/2004

                                                                                        Abstract

                                                                                        In 2000 a pilot study was conducted to evaluate the feasibility of a hepatitis B immunization project in prostitutes in the city of Antwerp. 108 sex workers participated in this project. Moreover, this project involves the broader subject of information and sensibilisation of prostitutes on STI's in particular and hygiene and condom use in general. This project will be continued in 2001 on a larger scale in the province of Antwerp with a larger availability of the medical and nursing staff. The continuity of the project still needs to be guaranteed by a structural funding.

                                                                                        Researcher(s)

                                                                                        Research team(s)

                                                                                          Preventative health promotion of prostitutes in Antwerp. 01/01/2002 - 31/12/2008

                                                                                          Abstract

                                                                                          In 1999-2000 a pilot study was conducted to evaluate the feasibility of a hepatitis B immunization project in prostitutes in the city of Antwerp. Moreover, this project involves the broader subject of information and sensibilisation of prostitutes on STI's in particular and hygiene and condom use in general. This project has been continued in 2001 and 2002 with restricted financing from Gh@pro vzw, to support that part of the personnel cost from the UA/CEV.

                                                                                          Researcher(s)

                                                                                          Research team(s)

                                                                                            Observer-blind, randomized, phase II clinical trial to assess the immunogenicity and safety of one dose of three formulations of dTpa vaccine containing 0,5mg, 0,3mg and 0,133mg of aluminium - 10 to 18 years. 30/10/2001 - 31/03/2002

                                                                                            Abstract

                                                                                            The aim of this clinical trial is to evaluate the effect of lowering the aluminium content of a In Europe licensed dTpa vaccine, Boostrix®, on its safety and immunogenicity. For this purpose, two new formulations of this vaccine containing 0.3 mg and 0.133 mg aluminium respectively, will be compared with Boostrix®, containing 0.5 mg aluminium. A total of 630 healthy subjects, aged 11-18 years, will be enrolled in this multicentric study, in 4 different centra. They will be randomly enrolled in three parallel groups, in which each individual will receive a single dose of one of the three compared formulations of the dTpa vaccine.

                                                                                            Researcher(s)

                                                                                            Research team(s)

                                                                                              Screening programme for sexually transmitted infections and hepatitis B vaccination of sex workers in the province of Antwerp. 01/10/2001 - 31/12/2003

                                                                                              Abstract

                                                                                              In 2000 a pilot study was conducted to evaluate the feasibility of a hepatitis B immunization project in prostitutes in the city of Antwerp. 108 sex workers participated in this project. Moreover, this project involves the broader subject of information and sensibilisation of prostitutes on STI's in particular and hygiene and condom use in general. This project will be continued in 2001 on a larger scale in the province of Antwerp with a larger availability of the medical and nursing staff. The continuity of the project still needs to be guaranteed by a structural funding.

                                                                                              Researcher(s)

                                                                                              Research team(s)

                                                                                                A phase II, open, randomised, multicentric study to evaluate the immunogenicity, reactogenicity and safety of combined high-dose hepatitis A/hepatitis B vaccine administred following an accelerated schedule -16 years. 03/09/2001 - 31/12/2002

                                                                                                Abstract

                                                                                                An accelerated schedule with Twinrix' Adult administered in 3 doses (0, 7, 21 days) and followed by another dose after one year, has been developed for subjects who need rapid protection against hepatitis A and hepatitis B. This schedule could be simplified by using a high-dose combined hepatitis A/hepatitis B vaccine (HAB 1440/40). A total of 140 healthy volunteers older than 16 years will participate in this study. The high-dose combined hepatitis A/hepatitis B vaccine (HAB 1440/40) will be given to 70 participants following a 3 dose schedule (day 0, day 21 and month 12). The 70 other participants will receive Twinrix'Adult (720/20) following a 4 dose vaccination schedule (day 0, day 7, day 21 and month 12). To evaluate the immunogenicity, 5 blood samples will be taken: on day 0, day 28, day 56, month 12 and month 13.

                                                                                                Researcher(s)

                                                                                                Research team(s)

                                                                                                  A phase III, single-blinded, randomized, multicentric study to compare the immunogenicity of thiomersal-free 2-dose Engerix TM-B and 3-dose preservative-free Engerix TM-B vaccines in volunteers. 15/08/2001 - 15/01/2003

                                                                                                  Abstract

                                                                                                  Engerix'-B has been licensed since 1986 and has an excellent safety and immunogenicity profile. Over 95% of the vaccinees are protected after vaccination. It exists in an adult formulation (20 mcg), to be used from the age of 16 onwards, and a paediatric formulation (10 mcg) for children 0-15 years. The vaccination schedule is 0-1-6 months. However, this vaccine contains thiomersal, an organomercury compound commonly used in vaccines and other products for parenteral use. On top of residual presence in the vaccine due to its use in the purification process of the antigen, thiomersal is added as a preservative in the final vaccine formulation. In 1999, both EMEA and FDA recommended to limit the use of mercuric compounds in vaccines as quickly as possible. In Europe and the US, the preservative-free Engerix'-B is currently licensed for use in children and adolescents. The thiomersal-free Engerix'-B is still under investigation. In this study, 2/3 of the 384 participants will receive 2 doses of the thiomersal-free Engerix'-B vaccine (20 mcg, adult formulation), according to a 0-6 months vaccination schedule (which is the schedule to be for adolescents). A control group (1/3) will receive the preservative-free vaccine (10 mcg) according to the classical 0-1-6 schedule. The ultimate goal is to reduce the number of doses, to simplify the schedule and to increase the acceptance of hepatitis B vaccination to the vaccinees.

                                                                                                  Researcher(s)

                                                                                                  Research team(s)

                                                                                                    A phase-III, randomized, single-blind clinical trial to assess the immune memory induced by undecavalent pneumococcal-protein D conjugate (11Pn-PD) vaccine in comparison with Prevenar TM in Belgium. 30/06/2001 - 30/04/2002

                                                                                                    Abstract

                                                                                                    A maximum of 284 children, aged 12-15 months, who have received primary pneumococcal vaccination in study Undeca-Pn-020 will be enrolled in the study. The children from each of the two original groups (11 Pn-PD or Prevenar') who take part to this study will be further divided into two groups. The sub-groups will then receive one booster dose either PNEUMOVAX' or 11 Pn-PD or Prevenar'. All children will also receive a booster dose of the routinely recommended DTPa-HBV-IPV/Hib vaccine. Two blood samples will be collected from each participant: - at the time of vaccination and 7 days later in case the participant receives Pneumovax' as booster vaccination. - at the time of vaccination and 30 days later in case the participant receives 11 Pn-PD or Prevenar' as booster vaccination. The diary cards will be collected by the investigator one month after vaccination.

                                                                                                    Researcher(s)

                                                                                                    Research team(s)

                                                                                                      A phase II, open, randomised, controlled study to evaluate the reactogenicity and safety of meningococcal CY conjugate candidate vaccine in healthy toddlers aged 24-30 months. 18/05/2001 - 18/01/2002

                                                                                                      Abstract

                                                                                                      The aim of this clinical study is to evaluate the safety and reactogenicity of a two-dose vaccination schedule with MenCY-PD in children 24-30 months of age prior to continuing clinical development in children below one year of age. Mencevax ACW135Y', which have been commercially available for years, is the control vaccine. A total of 60 healthy children aged 24-30 months will be enrolled in the study at a single centre. The children who take part in this study will be randomly placed in one of two groups. Each child in group A will receive 2 doses of the MenCY-PD vaccine with an interval of one month. Each child in group B will receive one dose of the Mencevax ACW135Y' vaccine.

                                                                                                      Researcher(s)

                                                                                                      Research team(s)

                                                                                                        Economic evaluation of vaccination programmes against airborne infections based on dynamic compartimental simulation models. 01/01/2001 - 31/12/2004

                                                                                                        Abstract

                                                                                                        The aim of this research project is to gain insight in the epidemiology and transmission dynamics of airborne infections and the influence of vaccination thereon by means of mathematica! simulation models. Economic evaluation of various vaccination strategies win be made an integral part of the models. The improvements in methodology and the results frorn applied analyses based on this research win be relevant for dornestic and foreign health policy and research.

                                                                                                        Researcher(s)

                                                                                                        Research team(s)

                                                                                                          Activities concerning the prevention of viral hepatitis B in Central and Eastern Europe and the Newly Independent States 01/01/2001 - 31/12/2004

                                                                                                          Abstract

                                                                                                          These activities concern the funding of the translation of VHPB publications in Russian, the participation of viral hepatitis experts from the eastern and central European countries at the Viral Hepatitis Prevention Board (VHPB) meetings and the organization of the June 2001 VHPB congress in Kiev on the introduction of a universal hepatitis B immunzation programme in countries in Central and Eastern Europe and the Newly Independent States.

                                                                                                          Researcher(s)

                                                                                                          Research team(s)

                                                                                                            Mathematic modelling and economic evaluation of vaccination programmes against airborne infections. 01/01/2001 - 31/12/2003

                                                                                                            Abstract

                                                                                                            There are three main objectives: (1) To develop a generic dynamic simulation model for the transmission of airborne infections; (2) To study the contact patterns between different age groups in Flanders; (3) To study the cost structure of the current vaccination programme against measles, mumps and rubella (MMR) in Flanders.

                                                                                                            Researcher(s)

                                                                                                            Research team(s)

                                                                                                              Study on the transmission dynamics of measles in the province of Antwerp and determination of the optimal vaccination strategies against measles based on epidemiological and economical evaluations. 01/01/2001 - 31/12/2002

                                                                                                              Abstract

                                                                                                              The aim of this study is twofold: firstly to gain insight in the epidemiology and transmission dynamics of measles and the influence of vaccination thereon; second to perform a model based economic evaluation of various vaccination strategies against measles in order to identify the most efficient options at om disposal. The relevance ofthe analysis will not be restricted to the province of Antwerp, as in most provinces and Emopean regiofiS the increased number of susceptible teenagers causes a threat to pubtic health, which is currently manifested through local outbreaks

                                                                                                              Researcher(s)

                                                                                                              Research team(s)

                                                                                                                Health promotion and hepatitis B vaccination of prostitutes in Antwerp 01/01/2001 - 31/12/2002

                                                                                                                Abstract

                                                                                                                The aim of this project is to give prostitutes free vaccination against hepatitis B. At the same time they are screened (HIV, syphilis, chlamydia, gonorrea) and given information about these infections, about the use of condom and hygiene in general. After the vaccination there is a new blood sampling to look at the immunogenicity. The intention is to continue to follow up the prostitutes and to screen them on STI's on a regular base.

                                                                                                                Researcher(s)

                                                                                                                Research team(s)

                                                                                                                  varicella sero-epidemiology in Flanders. 01/12/2000 - 31/12/2001

                                                                                                                  Abstract

                                                                                                                  Researcher(s)

                                                                                                                  Research team(s)

                                                                                                                    A phase III, randomized, single blind study to compare the immune responses induced by SmithKline Beecham Biologicals' undecavalent pneumococcal-protein D conjugate vaccine and by Prevnar TM, when administered to healthy infants, - 8- 16 weeks. 01/11/2000 - 31/12/2001

                                                                                                                    Abstract

                                                                                                                    The aim of the study is to evaluate the immunogenicity and reactogenicity in 100 infants (aged 8 to 16 weeks) of the eleven valent pneumococcal vaccine in comparison with the administration of the registered Prevnar vaccine, when given simultaneously with a six-component (DTPa-HBV-IPV-Hib) vaccine, according to a 3 doses schedule, 3, 4 and 5 month of age.

                                                                                                                    Researcher(s)

                                                                                                                    Research team(s)

                                                                                                                      Hepatitis B vaccination of prostitutes in Antwerp. 01/10/2000 - 30/09/2001

                                                                                                                      Abstract

                                                                                                                      In 2000 a pilot study was conducted to evaluate the feasibility of a hepatitis B immunization project in prostitutes in the city of Antwerp. Moreover, this project involves the broader subject of information and sensibilisation of prostitutes on STI's in particular and hygiene and condom use in general. This project will be continued in 2001 with restricted financing from Payoke vzw.

                                                                                                                      Researcher(s)

                                                                                                                      Research team(s)

                                                                                                                        A phase III double blind, randomised, multicentre study to evaluate the safety and consistency of 3 consecutive lots of SmithKline Beecham Biologicals' thiomersal-free Engerix-B vaccine containing 20mcg of HBsAg per 1.0ml dose - 18-40 years. 01/10/2000 - 30/09/2001

                                                                                                                        Abstract

                                                                                                                        A total of 150 healthy adult volunteers will receive 3 doses of hepatitis B vaccine according to a 0-1-6 months vaccination schedule. Each group (50 subjects per group) receives hepatitis B vaccines from a consecutive production lot without any use of thiomersal during the production process (thiomersal free). The immunogenicity will be assessed by means of regular blood samplings. Anamnestic data and diary cards will be used to register adverse reactions and to assess the reactogenicity and safety.

                                                                                                                        Researcher(s)

                                                                                                                        Research team(s)

                                                                                                                          Economic evaluation of varicella vaccination of adolescents in Italy and workers in paediatric institutions in France. 16/06/2000 - 31/03/2002

                                                                                                                          Abstract

                                                                                                                          The benefits of universal vaccination against chickenpox have been largely demonstrated in the recent literature. However, due to the potential risk of shifting the infection to older age groups where the disease is associated with severe complications, targeted vaccination may also prove beneficial. The current study uses cost-effectiveness and cost-benefit techniques to explore the efficiency of different vaccination strategies among two risk groups: Italian adolescents (11-years-old) and French workers in paediatric institutions). Health care payer, societal and employer (when relevant) point of views are considered. The strategies investigated are (1) no vaccination, (2) vaccination of the whole risk group , (3) vaccination of those with a negative or an uncertain history of chickenpox, (4) vaccination of those with a negative serological testing for chickenpox and (5) vaccination of those with a negative serological testing performed on those with a negative or an uncertain history of chickenpox. Each strategy is evaluated with the help of simulation models for single ageing cohorts. The validity of the results is explored by varying key variables. The comparability of the results with the existing literature for the adolescents target group only is further discussed.

                                                                                                                          Researcher(s)

                                                                                                                          Research team(s)

                                                                                                                            A phase II double-blind, randomised, controlled, multicentre study to evaluate the immunogenicity, safety and reactogenicity of preservative free Engerix-B and thiomersal free Engerix-B vaccines compared to licensed Engerix-B ...(18-50y.) 01/05/2000 - 28/02/2001

                                                                                                                            Abstract

                                                                                                                            A total of 618 healthy adult volunteers will receive 3 doses of hepatitis B vaccine according to a 0-1-6 months vaccination schedule. A (control) group receives a commercially available vaccine (Engerix'-B); another group gets the same vaccine without thiomersal (preservative free) and a third group receives the same vaccine without any use of thiomersal during the production process (thiomersal free). The immunogenicity will be assessed by means of regular blood samplings. Anamnestic data and diary cards will be used to register adverse reactions and to assess the reactogenicity and safety.

                                                                                                                            Researcher(s)

                                                                                                                            Research team(s)

                                                                                                                              Immunogenicity and safety of the concomitant administration of an hexavalent combined vaccine (DTaP-IPV-PRP~T-HBs) and an inactivated hepatitis A vaccine in healthy infants. A randomised comparative study. 01/02/2000 - 31/12/2001

                                                                                                                              Abstract

                                                                                                                              Because of their critical role in the transmission of hepatitis A, children could be a primary focus for hepatitis A immunisation strategy. A routine hepatitis A vaccination included in the early childhood vaccination schedule would lower the incidence of this infection. The combined hexavalent vaccine (DTaP-IPV-PRP~T-HBs) follows currently the European registration procedure; it will enhance the protection against several infections at the same time due to a better vaccination coverage as a consequence of the lower number of injections. 630 children (2 months old) are enrolled in this study: 250 infants in Belgium and 380 in Germany. All participants receive 4 doses of the hexavalent vaccine at 2, 4, 6 and 12 months of age. For the hepatitis A vaccine children are equally randomised into two groups: group 1 receives the hepatitis A vaccine at the age of 7 and 13 months, group 2 at the age of 6 and 12 months. During this study four blood samples are taken to evaluate the immunogenicity of both vaccines. The reactogenicity is evaluated the subjects diary card.

                                                                                                                              Researcher(s)

                                                                                                                              Research team(s)

                                                                                                                                Research on the IgG-specific pertussis antibodies. 01/10/1999 - 31/12/2000

                                                                                                                                Abstract

                                                                                                                                Several whole cell type pertussis vaccines and one acellular type pertussis vaccine are available in Belgium. All these vaccines are safe and very immunogenic. In the current sero-epidemiological study prevalence of pertussis antibodies is measured in a random sample of 1749 sera from an exiting serum bank. The research items are as follows: what is the distribution of the pertussis antibodies in the study population? Is there a link between immune response and gender/ age? How can we define the susceptible population? What is the longterm kinetics of the pertussis antibodies induced by vaccines? Results of this research could have important impact and consequences on the timing and planning of booster vaccination programme against pertussis.

                                                                                                                                Researcher(s)

                                                                                                                                Research team(s)

                                                                                                                                  Determination of the age-specific seroprevalence of antibody to HSV-1 and HSV-2 in eight European countries with comparable methodology. 01/10/1999 - 31/07/2000

                                                                                                                                  Abstract

                                                                                                                                  Herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) infections belong to the most common type of human viral infections. Orolabial herpes is usually caused by HSV-1, while genital herpes is usually caused by HSV-2. However, either type of virus is able to cause either type of clinical syndrome. HSV-1 is usually horizontally transmitted in childhood, although a dramatic decline in the rate of childhood infection has been observed in many countries because the socio-economic circumstances have significantly improved. HSV-2 is almost always sexually transmitted. In the past, the lack of reliable immunological tests to distinguish between antibodies to HSV-1 and HSV-2 and the fact that an unknown proportion of cases are not known to health services made it difficult to estimate the prevalence and relative importance of asymptomatic and symptomatic infections. The aim of the present project was to perform a cross-sectional study among the populations of eight European countries on stored sera, with the aid of the now available HSV-1 and HSV-2 specific antibody assays.

                                                                                                                                  Researcher(s)

                                                                                                                                  Research team(s)

                                                                                                                                    A clinical study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham Biologicals novel adjuvanted hepatitis B vaccine. 03/05/1999 - 25/03/2000

                                                                                                                                    Abstract

                                                                                                                                    The purpose of this study is to demonstrate the superiority of HBV-SBAS4 compared to Engerix'-B in terms of immunogenicity one month after the last vaccine dose, in 300 healthy volunteers older than 15 years and identified as HLA-DQ2 positive. The vaccines are administered according to a 0,6 and 0,1,6 month schedule, respectively. Furthermore, the safety and reactogenicity of the candidate vaccine will be evaluated and the immunogenicity at all time-points will be described.

                                                                                                                                    Researcher(s)

                                                                                                                                    Research team(s)

                                                                                                                                      Support to the participation of experts from central and eastern Europe and the Newly Independent States at VHPB conferences and activities - 1999. 01/01/1999 - 31/12/1999

                                                                                                                                      Abstract

                                                                                                                                      The project concerns the funding of the participation of a selected number of viral hepatitis experts from central and eastern Europe and the Newly Independent States at the Viral Hepatitis Prevention Board (VHPB) conferences entitled «control of hepatitis A / Impact of decision in France on Hepatitis B vaccination», «prevention and control of viral hepatitis in mobile population» and «behavioural issues in hepatitis control», organized by the Centre for Evaluation of Vaccination (CEV) in the framework of its secretarial support to the activities of the Viral Hepatitis Prevention Board (VHPB). Although these congresses mainly focus on the countries from Western Europe, issues specific for central and eastern Europe and the Newly Independent States are included in the programme. Moreover, the translation of VHPB publications in Russian will be funded by this project.

                                                                                                                                      Researcher(s)

                                                                                                                                      Research team(s)

                                                                                                                                        Support to the activities of the Viral Hepatitis Prevention Board (VHPB). 01/01/1999 - 31/12/1999

                                                                                                                                        Abstract

                                                                                                                                        The aim of the project is to promote the implementation of World Health Organisation (WHO) recommendations on viral hepatitis prevention and control in all European countries (Western Europe, Central and Eastern Europe, Newly Independent States of the former Soviet Union), in particular through functioning as the scientific secretariat of the International Viral Hepatitis Prevention Board (VHPB). The VHPB is an International, independent, multidisciplinary group of experts in the field of viral hepatitis. The objectives of the VHPB are to focus the attention on the risk of viral hepatitis, and to consider, recommend and encourage actions to improve the control and prevention of viral hepatitis. Priority collaborative actions in the framework of this project are: to organise International meetings of viral hepatitis experts to elaborate technical guidelines on all aspects of viral hepatitis prevention and control; to produce and disseminate scientific information for health decision-makers and health professionals (Newsletter'Viral Hepatitis'); to increase the awareness of the public at large on the importance of viral hepatitis prevention through media campaigns and health promotion materials.

                                                                                                                                        Researcher(s)

                                                                                                                                        Research team(s)

                                                                                                                                          Infectious Diseases in Flanders: listing of surveillance networks and aggregation of surveillance data for selected infectious diseases. 15/12/1998 - 30/04/1999

                                                                                                                                          Abstract

                                                                                                                                          Registration of infectious diseases is important in the control of infectious diseases, as well on the field (in providing data and helping to control outbreaks) as for the Public Health authorities. Indeed, infectious diseases data are likely to influence the vaccination policy and the planning of health care resources, health information or funding for campaigns and projects. Surveillance of infectious diseases generates useful data on drug treatment and microbial resistance patterns. In Flanders, multiple networks are involved in gathering infectious disease data. Based on interview with the responsible persons, the methodology of 9 such networks has been assessed thoroughly and a few other networks have been described shortly. A description of 50 selected infectious diseases (notifiable and/or preventable through vaccination and/or with high societal impact) has been given. A clinical case definition, an overview of (inter)national goals for their control and an overview of the existing registration data for Flanders/Belgium has been added. Where possible, data have been compared to one another and it has been assessed whether the set targets would be reachable. Finally, suggestions have been made to improve the efficiency and the mutual collaboration of the separate networks

                                                                                                                                          Researcher(s)

                                                                                                                                          Research team(s)

                                                                                                                                            Prevention and control of Hepatitis B in selected countries of CCE and NIS : economic evaluation of universal infant immunisation programmes. 01/12/1998 - 31/05/2002

                                                                                                                                            Abstract

                                                                                                                                            This project aims to address issues related to the implementation of universal hepatitis B vaccination in selected countries of Central and Eastern Europe and the Newly Independent States. Countries involved in the project are Bulgaria, Russia, Moldova and Uzbekistan. This project will focus on the economic evaluation of this preventive intervention. The main objectives of the project are a) to raise the awareness among health partners, policy makers and health care providers about heaptitis B as a public health problem; b) to summarise available socio-demographic and epidemio-logical data; c) to study the economic efficiency of universal hepatitis B immunisation programmmes; d) to disseminate and promote the findings in formats relevant for policy development and advocacy. To achieve the above objectives, activities will be organised with public health officials, experts and international donors in order to put hepatitis B on the political agenda. These activities will be based on existing epidemiological data and newly generated input. The cost-effectiveness of universal hepatitis B vaccination will be evaluated given the local economic situation in the selected countries and research findings will be disseminated. Training seminars will be organised and publications will be distributed both in English and in Russian.

                                                                                                                                            Researcher(s)

                                                                                                                                            Research team(s)

                                                                                                                                              Coverage measurement of the routine infant immunization in Flanders. 01/12/1998 - 30/10/1999

                                                                                                                                              Abstract

                                                                                                                                              A collaboration project was started with the administration of the Ministry of Flemish Affairs and the Free University of Brussels to set up a coverage measurement among 1100 Flemish children using the cluster sampling method.

                                                                                                                                              Researcher(s)

                                                                                                                                              Research team(s)

                                                                                                                                                A double blind phase II trial to compare the immunogenicity of Hib conjugate vaccine as a primary vaccination course in healthy infants at 3, 4 and 5 months of age. 01/12/1998 - 30/06/1999

                                                                                                                                                Abstract

                                                                                                                                                This clinical study will evaluate the reactogenicity ( appearance of side effects ) and the immunogenicity ( stimulation of antibody protection ) of a primary vaccination course of SB Biologicals' DTPa-HBV-IPV vaccine ( a combined diphteria-tetanus-acellular pertussis-hepatitis B-polio vaccine ) mixed with SB biologicals' Hib conjugate vaccine (a haemophilus influenzae type B vaccine ) at two different concentrations, and administered as a single injection to infants at 3, 4 and 5 months of age. The results obtained after administration of the two concentrations will be compared.

                                                                                                                                                Researcher(s)

                                                                                                                                                Research team(s)

                                                                                                                                                  A prevalence study, in a healthy population aged 15 to 50 years, to determine the prevalence of HLA-DQ2 which is known to influence the immune response to hepatitis B vaccination. 01/12/1998 - 31/03/1999

                                                                                                                                                  Abstract

                                                                                                                                                  Genetic predisposition has been described as one of the factors contributing to non- responsiveness to the hepatitis B vaccine. The haplotype HLA-DQ2 is known to have a negative impact on the immune response to the hepatitis B vaccination. The purpose of this prevalence study is to get more accurate data on the prevalence of HLA-DQ2 in a healthy population in Western-Europe. One blood sample will be taken from 1000 healthy male and female subjects aged between 15 ' 50 years, to determine HLA-DQ2 and identify HBV markers.

                                                                                                                                                  Researcher(s)

                                                                                                                                                  Research team(s)

                                                                                                                                                    Economic evaluations of hepatitis B vaccination: a global review of recent studies (1993-1999) 16/11/1998 - 31/01/1999

                                                                                                                                                    Abstract

                                                                                                                                                    A search was carried out for economic evaluations of hepatitis B vaccination, published between 1993 and 1999. The methodology and results were discussed, according to the level of endemicity. The great majority of these studies were carried out for developed countries, for the most part situated in areas of low hepatitis B endemicity. In countries of very low endemicity economic evaluations have yielded contradictory results. The addition of universal to existing selective vaccination strategies depends on the level of confidence these countries have in their ability to sufficiently identify, reach and fully vaccinate persons in various risk groups. In areas where endemicity is higher (low, intermediate and high) universal vaccination was found to be justified on the basis of cost-effectiveness. More studies seem to be needed to persuade decision makers to include hepatitis B vaccination in routine immunisation programs in countries of high endemicity. The few existing studies for these countries reveal a great economic potential of such programs. In general the accuracy of modeling the spread of infection and the evolution of HBV disease has improved over the years, but still the clarity, completeness and comparability of analyses could improve considerably. Specific guidelines for economic evaluations of the prevention of infectious diseases would be helpful

                                                                                                                                                    Researcher(s)

                                                                                                                                                    Research team(s)

                                                                                                                                                      Mathematical modeling of infectious diseases 01/10/1998 - 31/12/1999

                                                                                                                                                      Abstract

                                                                                                                                                      On the basis of existing models a complex compartimental simulation model will be developed to mimic the spread of infectious diseases and the impact of vaccination strategies thereon in the general population. To this end demographic, epidemiological and vaccine-specific characteristics are combined in a so-called SIR-model (Susceptible-Infected-Recovered). This model will be adapted and used for a number of vaccine-preventable infectious diseases.

                                                                                                                                                      Researcher(s)

                                                                                                                                                      Research team(s)

                                                                                                                                                        A phase III double-blind randomised study designed to evaluate the consistency of 3 consecutive production lots of a combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine in healthy volunteers aged 15-50 years. 01/03/1998 - 30/06/1998

                                                                                                                                                        Abstract

                                                                                                                                                        This vaccine study aims at analyzing the consistency of 3 consecutive production lots of a combined typhoid and hepatitis A candidate vaccine, in terms of imrnunogenicity and safety profile.

                                                                                                                                                        Researcher(s)

                                                                                                                                                        Research team(s)

                                                                                                                                                          Support to the activities of the Viral Hepatitis Prevention Board (VHPB). 01/02/1998 - 31/12/1998

                                                                                                                                                          Abstract

                                                                                                                                                          The aim of the project is to promote the implementation of World Health Organisation (WHO) recommendations on viral hepatitis prevention and control in all European countries (Western Europe, Central and Eastern Europe, Newly Independent States of the former Soviet Union), in particular through functioning as the scientific secretariat of the International Viral Hepatitis Prevention Board (VHPB). The VHPB is an International, independent, multidisciplinary group of experts in the field of viral hepatitis. The objectives of the VHPB are to focus the attention on the risk of viral hepatitis, and to consider, recommend and encourage actions to improve the control and prevention of viral hepatitis. Priority collaborative actions in the framework of this project are: to organise International meetings of viral hepatitis experts to elaborate technical guidelines on all aspects of viral hepatitis prevention and control; to produce and disseminate scientific information for health decision-makers and health professionals (Newsletter'Viral Hepatitis'); to increase the awareness of the public at large on the importance of viral hepatitis prevention through media campaigns and health promotion materials.

                                                                                                                                                          Researcher(s)

                                                                                                                                                          Research team(s)

                                                                                                                                                            A phase IIa, double-blind, randomised clinical study to evaluate the safety and immunogenicity of 2 formulations of a tetravalent pneumococcal-protein D conjugate vaccine in healthy children aged 12-14 months being administered 1 single dose of vaccine. 01/02/1998 - 30/04/1998

                                                                                                                                                            Abstract

                                                                                                                                                            In this clinical study 50 children, aged 12-14 months, will be vaccinated with 1of 2 formulations of a tetravalent congugated pneumococcoal candidate vaccine in order to assess the immunogenicity and safety of these formulations. This study is carried out in collaboration with the Mother & Child Clinics in Flanders (Kind & Gezin).

                                                                                                                                                            Researcher(s)

                                                                                                                                                            Research team(s)

                                                                                                                                                              A study to evaluate the immunogenicity, safety and reactogenicity of hepatitis A/hepatitis B vaccine (Twinrix) administered following a 2 dose schedule in healthy children aged 1 to 11 years included. 01/01/1998 - 31/03/2003

                                                                                                                                                              Abstract

                                                                                                                                                              There is currently no treatment for either hepatitis A or hepatitis B. It has been recognised that vaccination is the only method of conferring long-term protection against clinical disease and/or infection. A combined vaccine is available as Twinrix for adults/adolescents and Twinrix junior for children, both administered in a 3 close schedule (0, land 6 months). In the current study, Twinrix for adults, will be used in a 2 close vaccination schedule (0, 6 month) for 240 children between 1 and 11 years (included) to achieve a short vaccination schedule and enhance the acceptance of immunisation by both the general public and the medical community. During the study, blood will be taken to evaluate the irnmunogenicity. The reactogenicity will be accessed through recording side effects after vaccination.

                                                                                                                                                              Researcher(s)

                                                                                                                                                              Research team(s)

                                                                                                                                                                Transmission of measles in Flanders : an epidemiological and economic evaluation of various vaccination strategies. 01/01/1998 - 31/12/1999

                                                                                                                                                                Abstract

                                                                                                                                                                The aim of this study is twofold: firstly to gain insight in the epidemiology and transmission dynamica of measles and the influence of vaccination thereon; second to perform a model based economic evaluation of various vaccination strategies against measles in order to identify the most efficiÙnt options at our disposal. Although the analysis will be carried out for the region of Flanders (Belgium), its relevance is not restricted to this area, as in most European countries the increased number of susceptible teenagers causes a threat to public health, which is currently manifested through local epidemic outbreaks.

                                                                                                                                                                Researcher(s)

                                                                                                                                                                Research team(s)

                                                                                                                                                                  Sero-epidemiological survey on pertussis antibodies in the general population, Flanders. 01/12/1997 - 30/09/1998

                                                                                                                                                                  Abstract

                                                                                                                                                                  The aim of this project is the sero-epidemiological analysis of the immunity against pertussis in the general population in Flanders. This policy-oriented research is to provide an answer to the issue of the level of immunity in the the general population, and to identify the proportion of susceptible individuals.

                                                                                                                                                                  Researcher(s)

                                                                                                                                                                  Research team(s)

                                                                                                                                                                    Illicit drug use in Antwerp (Belgium): A study in the Antwerp District Court, 1997. 01/12/1997 - 31/03/1998

                                                                                                                                                                    Abstract

                                                                                                                                                                    Of all illicit drug users who came into contact with the police between September 10 and December 10, 1997 and who were hooked within the legal district of Antwerp, a number of data were collected (age, sex, nationality, residence, previous drug-related contact with the law, substances used). These data were analysed and compared to those of other legal districts in Flanders and to earlier Antwerp data. Since this registration study started in 1990, a comparison over several years is possible.

                                                                                                                                                                    Researcher(s)

                                                                                                                                                                    Research team(s)

                                                                                                                                                                      Support to the participation of experts from central and eastern Europe and the Newly Independent States at the VHPB Congress in Madrid, Spain, 17-19 November 1997. 17/11/1997 - 19/11/1997

                                                                                                                                                                      Abstract

                                                                                                                                                                      The project concerns the funding of the participation of a selected number of viral hepatitis experts at the VHPB Congress entitled 'Control of Hepatitis B in Europe: Where are we now?', organised by the Centre for the Evaluation of Vaccination (CEV) in the framework of its secretarial support to the activities of the Viral Hepatitis Prevention Board (VH PB). The main aim of this meeting was to take stock of the present status regarding the implementation of the WHO recommendation that all countries should integrale hepatitis B vaccine into their national immunisation programmes by 1997. Although the congress was mainly focussing on the countries from Western Europe, issues specific for central and eastern Europe and the Newly Independent States were also included in the programma. Therefore, ten key experts from eastern Europe and Russia were invited to the meeting.

                                                                                                                                                                      Researcher(s)

                                                                                                                                                                      Research team(s)

                                                                                                                                                                        A single-blind, randomised study comparing the immunogenicity and reactogenicity of recombinant hepatitis B - MPL vaccine in an adult population aged between 50 and 70 years. 01/11/1997 - 31/01/1999

                                                                                                                                                                        Abstract

                                                                                                                                                                        The aim of this study is to compare the immunogenicity and reactogenicity of a hepatitis B candidate vaccine (double close of HBsAg, containing MPL) to the immunogenicity and reactogenicity of Engerix-B in 160 healthy volunteers aged between 50 and 70 years. According to a 0-1-6 months vaccination schedule, 3 doses of the vaccine will be administered. Subjects will be randomised over 2 groups: one group receiving the candidate vaccine, the other group being vaccinated with Engerix-B. The goal of this programme is to develop a more immunogenic hepatitis B vaccine, that can be used in persons with a lowered immune response.

                                                                                                                                                                        Researcher(s)

                                                                                                                                                                        Research team(s)

                                                                                                                                                                          Program evaluation of vaccination against influenza of possible pandemie impact. 01/11/1997 - 31/12/1997

                                                                                                                                                                          Abstract

                                                                                                                                                                          This study involves calculations of incremental economic costs and medical effects of influenza vaccination of risk groups and the general population in Belgium. The possibility of a pandemic will be taken into account. The calculations will be performed by means of a mathematical simulation model that is specifically developed for this study.

                                                                                                                                                                          Researcher(s)

                                                                                                                                                                          Research team(s)

                                                                                                                                                                            An open, randomised study to compare the reactogenicity and immunogenicity of a combined high-dose hepatitis A / hepatitis B vaccine (Twinrix Junior). 01/10/1997 - 30/09/1998

                                                                                                                                                                            Abstract

                                                                                                                                                                            The primary objective of this study is to compare the reactogenicity and safety of the high-dose combined vaccine to that of Twinrix Junior. The secondary objective is to compare the immunogenicity of the two vaccines. This will be done by administering both vaccines to healthy volunteers between 11 and 18 years of age. The total number of subjects in the study will be 100; each vaccine will be given at random to 50 subjects. Because of the different vaccination schedule for the two vaccines under study, a blinded study design was impossible.

                                                                                                                                                                            Researcher(s)

                                                                                                                                                                            Research team(s)

                                                                                                                                                                              An open, non-randomised study to evaluate the safety and immunogenicity of 3 formulations of candidate therapeutic vaccines (containing L2E7 antigen and SBAS2 adjuvans) against genital warts in healthy adult volunteers. 01/10/1997 - 30/09/1998

                                                                                                                                                                              Abstract

                                                                                                                                                                              This study intends to measure the immunogenicity and to evaluate the safety and reactogenicity of 3 doses (30 Ág, 100 Ág and 300 Ág) of the L2E7 antigen. During the study, each subject will receive 3 doses of their assigned vaccine at monthly interval. The study will be conducted according to a stepwise fashion: ten subjects will receive the lowest dose (30 Ág); if no untoward symptoms occur, a second group of 10 subjects will receive the next higher dose.

                                                                                                                                                                              Researcher(s)

                                                                                                                                                                              Research team(s)

                                                                                                                                                                                A phase IIa, double-blind, randomised, comparative, multicentre study of the immunogenicity, reactogenicity and safety of a single intramuscular close of 1 of 3 formulations of the candidate RSV vaccine in healthy adults aged over 65 years. 01/09/1997 - 31/12/1997

                                                                                                                                                                                Abstract

                                                                                                                                                                                According to the immunogenicity data and safety-profile of the RSV-vaccine in this study (performed in a +65 years old group of participants), the optimal antigen-dose will be determined for further analysis with the candidate vaccine.

                                                                                                                                                                                Researcher(s)

                                                                                                                                                                                Research team(s)

                                                                                                                                                                                  Single-blind, randomised, comparative study to evaluate the reactogenicity and immunogenicity of two lots of inactivated hepatitis A vaccines. 01/01/1997 - 31/12/1998

                                                                                                                                                                                  Abstract

                                                                                                                                                                                  The primary aim of this study is to assess the safety and reactogenicity of the different lots of the vaccine. In addition, the immunogenicity of the different lots of the vaccine will be evaluated. A total of 300 healthy adult volunteers will be divided at random into 3 groups of 100 subjects, each of which will receive a different lot of the vaccine.

                                                                                                                                                                                  Researcher(s)

                                                                                                                                                                                  Research team(s)

                                                                                                                                                                                    A double-blind, randomised, placebo-controlled study to evaluate the safety of a Herpes simplex candidate vaccine (gD2t) with MPL in HSV seropositive or seronegative subjects without genital herpes disease. 01/01/1997 - 31/12/1998

                                                                                                                                                                                    Abstract

                                                                                                                                                                                    The aim of this study is to compare the safety of SmithKline Beecham BiologicalsÆ Herpes simplex vaccine with a placebo. Both will be administered to healthy, HSV seropositive or seronegative adults according to a 0-1-6 months vaccination schedule. In addition, the reactogenicity and immunogenicity of the vaccine , as well as the effect on biochemical and haematological parameters will be assessed. This study will be conducted in multiple centres world-wide, and will include 6500 subjects. Subjects will be divided into the groups at random; 2/3 of all vaccinees will receive the vaccine, 1/3 will receive the placebo. Our study centre will enrol 200 subjects.

                                                                                                                                                                                    Researcher(s)

                                                                                                                                                                                    Research team(s)

                                                                                                                                                                                      Illicit drug use in Flanders (Belgium) : a study in Flemish district courts. 01/01/1997 - 31/12/1997

                                                                                                                                                                                      Abstract

                                                                                                                                                                                      Yearly registration of booked drug users shows that there is a yearly change in used products. Cannabis remains the most important illicit drug and the popularity of heroin and cocaine decreases. XTC and amphetamines become more and more important. The major part of the population is formed by men, but at the lowest age categories females contribute relatively more to the booked drug users. The mean age of the group of veralized drug users is 23 years. The proportion younger than 16 years is augmenting.

                                                                                                                                                                                      Researcher(s)

                                                                                                                                                                                      Research team(s)

                                                                                                                                                                                        Costs of varicella and cost-effectiveness of varicella vaccination in Belgium. 01/01/1997 - 31/12/1997

                                                                                                                                                                                        Abstract

                                                                                                                                                                                        By means of a survey, an analysis is made of the evolution of the incidence of varicella in Belgium and the direct and indirect costs associated with varicella. Furthermore a model based economic evaluation is performed of various vaccination strategies against varicella in order to identify the most efficient alternatives.

                                                                                                                                                                                        Researcher(s)

                                                                                                                                                                                        Research team(s)

                                                                                                                                                                                          An open study to evaluate the safety and immunogenicity of a combined hepatitis A / hepatitis B vaccine containing 720 El.U of hepatitis A antigen and 20 Ág of hepatitis B surface antigen, in healthy adolescent volunteers. 01/01/1997 - 31/12/1997

                                                                                                                                                                                          Abstract

                                                                                                                                                                                          The primary objective of this study is to evaluate the reactogenicity and safety of the combined hepatitis A - hepatitis B vaccine. The secondary objective is to assess the immunogenicity of the vaccine. This will be done by administering the vaccine to healthy volunteers between 11 and 18 years of age. The total number of subjects in the study will be 60.

                                                                                                                                                                                          Researcher(s)

                                                                                                                                                                                          Research team(s)

                                                                                                                                                                                            A phase III, blinded comparative clinical study of the immunogenicity, reactogenicity and safety of a single booster dose of candidate dTpa and pa vaccines and licensed Td vaccine in healthy adults aged > 18 years. 01/01/1997 - 31/12/1997

                                                                                                                                                                                            Abstract

                                                                                                                                                                                            The aim of this study is to evaluate the immunogenicity, reactogenicity and safety of a single booster close of dTpa and pa candidate vaccines and licensed Td vaccine in healthy adults 18 years and older. Furthermore, the immune status of the study population before the booster dose will be assessed and the cellular immune response to the pertussis booster will be evaluated in a subset of the subjects. A total of 300 subjects will be randomly attributed to one of the vaccine groups and thus receive a single booster of one of the 3 vaccines under study. This study programme aims to add valuable information concerning the boostering policy against tetanus, but especcially against diphteria and pertussis.

                                                                                                                                                                                            Researcher(s)

                                                                                                                                                                                            Research team(s)

                                                                                                                                                                                              A seroepidemiological study to determine HSV-1 and HSV-2 seroprevalence in medical students and hospital personnel. (HSV011). 01/10/1996 - 31/12/1998

                                                                                                                                                                                              Abstract

                                                                                                                                                                                              In this epidemiological study, a group of medica', students and hospital personnel will be tested for the presence of HSV-1 and HSV-2. The purpose of this study is to evaluate the seropreva',ence of the Herpes simplex virus, the seropreva',ence per subtype (HSV-1 and HSV-2) and to determine any association between demographic factors (age, gender, race, sexual background) and serological markers.

                                                                                                                                                                                              Researcher(s)

                                                                                                                                                                                              Research team(s)

                                                                                                                                                                                                Open study, to evaluate the reactogenicity, and immunogenicity of an inactivated hepatitis A vaccine containing 1440 El.U. of antigen per ml. and injected in healthy children according to a 0-6 month schedule. 01/07/1996 - 30/06/1997

                                                                                                                                                                                                Abstract

                                                                                                                                                                                                In this clinical trial, a double dose of the existing hepatitis A vaccine is administered. This new vaccination schedule and dosage has established excellent results in previous studies in adolescents and adults, allowing us to give vaccinees good protection against hepatitis A, even after a single dose. The purpose of this study is to evaluate the immunogenicity and reactogenicity of this new vaccination schedule and dosage in children, aged 5-12 years.

                                                                                                                                                                                                Researcher(s)

                                                                                                                                                                                                Research team(s)

                                                                                                                                                                                                  Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three hepatitis A vaccines injected according to a 0,6 months schedule in healthy adult volunteers. 01/07/1996 - 30/06/1997

                                                                                                                                                                                                  Abstract

                                                                                                                                                                                                  In this clinical study, the reactogenicity and immunogenicity of three different lots of a new hepatitis A vaccine (produced following a more purified method) will be compared to each other. The purpose of this study is to evaluate if three lots of vaccine can be produced with the same quality.

                                                                                                                                                                                                  Researcher(s)

                                                                                                                                                                                                  Research team(s)

                                                                                                                                                                                                    A study to compare the reactogenicity and immunogenicity of high-dose hepatitis A hepatitis/B vaccine to those of high dose Havrix vaccine and Engerix-B vaccine administered simultaneously in opposite arms, on healthy adults. 01/07/1996 - 30/06/1997

                                                                                                                                                                                                    Abstract

                                                                                                                                                                                                    In this clinical study, the reactogenicity and immunogenicity of a combined hepatitis A/hepatitis B vaccine is compared to high-dose vaccines, administered simultaneously, but separately, in opposite arms. The purpose of this combined vaccine is to facilitate the vaccination of individuals against both infections, to increase the compliance and acceptance.

                                                                                                                                                                                                    Researcher(s)

                                                                                                                                                                                                    Research team(s)

                                                                                                                                                                                                      Double-blind, randomised study to evaluate the immunogenicity and reactogenicity of hepatitis A vaccines injected according to a 0,6 month schedule in healthy adult volunteers. 01/10/1995 - 31/12/1996

                                                                                                                                                                                                      Abstract

                                                                                                                                                                                                      Tn this clinical study the reactogenicity and immunogenicity of three different lots of a new hepatitis A vaccine - produced following a more purified method - are evaluated. The purpose of this new production process is to produce a purer vaccine that is still immunogenic.

                                                                                                                                                                                                      Researcher(s)

                                                                                                                                                                                                      Research team(s)

                                                                                                                                                                                                        Double-blind, randomised, comparative study to evaluate the immunogenicity and reactogenicity of hepatitis A vaccine (Havrix), both containing 1440 El.U. of antigen in healthy adult volunteers. 01/10/1995 - 30/06/1996

                                                                                                                                                                                                        Abstract

                                                                                                                                                                                                        In this clinical study the reactogenicity and immunogenicity of a new hepatitis A vaccine produced following a more purified method - is compared to the commercialised hepatitis A vaccine. The purpose of this new production process is to produce a purer vaccine that is still immunogenic.

                                                                                                                                                                                                        Researcher(s)

                                                                                                                                                                                                        Research team(s)

                                                                                                                                                                                                          An observer-blind, randomised, parallel, single-center, phase III study to evaluate the safety, tolerability and immunogenicity of Influvac inactivated subunit influenza virus vaccine administered to healthy elderly persons. 01/07/1995 - 30/06/1997

                                                                                                                                                                                                          Abstract

                                                                                                                                                                                                          Current available influenza vaccines only offer a 30 to 70% protection. Vaccine manufacturers try to improve the existing influenza vaccines by adding an immunestimulator/modulator. In this clinical trial 300 healthy elderly people (>65 years) will be divided into two groups, receiving the classical influenza vaccine or the trial vaccine. Immunogenicity and reactogenicity will recorded during 3 months.

                                                                                                                                                                                                          Researcher(s)

                                                                                                                                                                                                          Research team(s)

                                                                                                                                                                                                            Hepatitis B immunization of judicial police officers and evaluation of the immunization programme. 01/03/1995 - 28/02/1997

                                                                                                                                                                                                            Abstract

                                                                                                                                                                                                            Judicial police officers could show an occupational exposure to hepatitis B, due to parental and horizontal hepatitis B transmission. Prevalence study in order to analyse the potential additional risk for hepatitis B exposure compared to the general population. Start a hepatitis B immunization programme. Method : pre-vaccination screening; registration, immunization.

                                                                                                                                                                                                            Researcher(s)

                                                                                                                                                                                                            Research team(s)

                                                                                                                                                                                                              Costs and benefits of routine vaccination in Germany. 01/01/1995 - 30/06/1995

                                                                                                                                                                                                              Abstract

                                                                                                                                                                                                              An economic evaluation (cost-effectiveness and cost-benefit analysis) of routine varicella vaccination was performed comparing four different strategies: doing nothing; routine vaccination of infants (12 to 18 month old); routine vaccination of susceptible adolescents (12 year olds); and simultaneous vaccination of children and adolescents (catch-up) during 11 years followed by the second strategy. From an economic point of view, the adolescent vaccination is the most effective. Based on economic evaluation and taking ethical and medical arguments into consideration, the catch-up strategy is the most optimal.

                                                                                                                                                                                                              Researcher(s)

                                                                                                                                                                                                              Research team(s)

                                                                                                                                                                                                                The epidemiology of Chronic Hepatitis. 01/01/1995 - 30/04/1995

                                                                                                                                                                                                                Abstract

                                                                                                                                                                                                                Problem: for the moment no accurate date is available on the burden of disease of hepatitis B in Europe and North-America. Aim: based on the current literature snd surveillance data in Europe and North-America to create a reliable image of the number of chronic complications of hepatitis B, in order to evaluate a therapeutic intervention. Methods: to build up a computer simulation model (Turbo Pascal) in which the hepatitis B disease evolution is modelled.

                                                                                                                                                                                                                Researcher(s)

                                                                                                                                                                                                                Research team(s)

                                                                                                                                                                                                                  An open, randomised, controlled study among HSV seropositive individuals in order to assess the safety, reactogenicity and immunogenicity of an Herpes Simplex candidate vaccine. 01/12/1994 - 28/02/1996

                                                                                                                                                                                                                  Abstract

                                                                                                                                                                                                                  This clinical trial is a phase 1 trial. In this clinical trial a candidate Herpes Simplex (HS) vacci ne is assessed in terms of safety, reactogenicity and antibody-production among individuals with a positive history (and serologically confirmed) of herpes simplex. The purpose of this vaccination is to work therapeutically so that the number of HS episodes decreases.

                                                                                                                                                                                                                  Researcher(s)

                                                                                                                                                                                                                  Research team(s)

                                                                                                                                                                                                                    Support to the administrative and operational activities of the Executive Secretariat of the Viral Hepatitis Prevention Board, Dept. of Epidemiology, University of Antwerp. 01/11/1994 - 31/12/1998

                                                                                                                                                                                                                    Abstract

                                                                                                                                                                                                                    The Viral Hepatitis Prevention Board (VHPB) is an independent, international, multidisciplinary group of experts established to focus attention on the risks of viral hepatitis in Europe and North America, and to consider, make recommendation on, and encourage actions to improve the control and prevention of viral hepatitis. The board is supported by an Execu tive secretariat, which is located in the Department of Epidemiology and Community Medicine of the University of Antwerp Belgium.

                                                                                                                                                                                                                    Researcher(s)

                                                                                                                                                                                                                    Research team(s)

                                                                                                                                                                                                                      New formuation hepatitis B vaccine: clinical trial to assess safety and immunogenicity in healthy adolescents. 01/10/1994 - 31/10/1999

                                                                                                                                                                                                                      Abstract

                                                                                                                                                                                                                      In 5 % to 10 % of the healthy adolescents which are vaccinated with the classical recombinant DNA hepatitis B vaccins, no immune response occurs. Therefore, the activity of a new hepatitis B vaccine will be evaluated in this clinical trial; this vaccine shows a different formulation (which could better stimulate the immune response) compared to the classical one.

                                                                                                                                                                                                                      Researcher(s)

                                                                                                                                                                                                                      Research team(s)

                                                                                                                                                                                                                        New formulation hepatitis B vaccine: clinical trial to assess safety and immunogenicity in healthy children. 01/10/1994 - 31/12/1995

                                                                                                                                                                                                                        Abstract

                                                                                                                                                                                                                        In 5 % of the healthy children which are vaccinated with the classical recombinant DNA hepatitis B vaccins, no immune response occurs. Therefore, the activity of a new hepatitis B vaccine will be evaluated in this clinical trial; this vaccine shows a different formulation (which could better stimulate the immune response) compared to the classical one.

                                                                                                                                                                                                                        Researcher(s)

                                                                                                                                                                                                                        Research team(s)

                                                                                                                                                                                                                          New formuation hepatitis B vaccine. Clinical trial to assess safety and immunogenicity in healthy adults. 01/10/1994 - 31/12/1995

                                                                                                                                                                                                                          Abstract

                                                                                                                                                                                                                          In 10% of the healthy adults which are vaccinated with the classical recombinant DNA hepatitis B vaccins, no immune response occurs. Therefore, the activity of a new hepatitis B vaccine will be evaluated in this clinical trial; this vaccine shows a different formulation (which could better stimulate the immune response) compared to the classical one.

                                                                                                                                                                                                                          Researcher(s)

                                                                                                                                                                                                                          Research team(s)

                                                                                                                                                                                                                            An open, randomised, controlled clinical study among HSV seronegative individuals in order to assess the safety, reactogenicity and immunogenicity of an Herpes Simplex candidate vaccine. 01/10/1994 - 31/12/1995

                                                                                                                                                                                                                            Abstract

                                                                                                                                                                                                                            This clinical study is a phase 1 trial. In this trial a candidate Herpes Simplex (HS) vaccine is assessed in terms of safety, reactogenicity and antibo dy-production among individuals with no history of herpes simplex (serologically HSV-negative). The purpose of this vaccination is to offer protection against infection among immunized individuals.

                                                                                                                                                                                                                            Researcher(s)

                                                                                                                                                                                                                            Research team(s)

                                                                                                                                                                                                                              Vaccine-trial, testing a new seed of yeast for recombinant hepatitis B vaccine production. 01/10/1994 - 31/03/1995

                                                                                                                                                                                                                              Abstract

                                                                                                                                                                                                                              Recombinant hepatitis B vaccines are produced using genetic engineering techniques, based on mammarian cell-line or on yeast. In this trial, a recombinant hepatitis B vaccine is used; the production of this vaccine is based on a second yeast-type. In this trial (n=150) the reactogenicity are measured, in a population of healthy volunteers.

                                                                                                                                                                                                                              Researcher(s)

                                                                                                                                                                                                                              Research team(s)

                                                                                                                                                                                                                                Registration survey among drugusers. 01/01/1994 - 31/12/1994

                                                                                                                                                                                                                                Abstract

                                                                                                                                                                                                                                In collaboration with the Antwerp Drug Platform, since 1989 an annual survey is carried out among drugusers, concerning the drug use and typology of the druguser. For the moment in Flanders, 10 justitial departments participate in this survey.

                                                                                                                                                                                                                                Researcher(s)

                                                                                                                                                                                                                                Research team(s)

                                                                                                                                                                                                                                  Open standardized immunogenicity and reactogenicity study of a recombinant DNA hepatitis B vaccine comparing 2 ways of administration. 01/01/1994 - 31/12/1994

                                                                                                                                                                                                                                  Abstract

                                                                                                                                                                                                                                  The administration of the recombinant DNA hepatitis B vaccine via Jetgun will be compared with the needle and springe system, in terms of immunogenicity and reactogenicity.

                                                                                                                                                                                                                                  Researcher(s)

                                                                                                                                                                                                                                  Research team(s)

                                                                                                                                                                                                                                    Dubbel-blind, multicenter randomized study on the immunogenicity and reactogenicity of a new candidate hepatitis B vaccine. 01/01/1994 - 31/12/1994

                                                                                                                                                                                                                                    Abstract

                                                                                                                                                                                                                                    With the classical recombinant DNA hepatitis B vaccine, 5 to 10 % of the vaccinees remain non-responders. Therefore, the effect of a new hepatitis B vaccine will be examined; this vaccine contains a specific adjuvans, which could stimulate the immune respons.

                                                                                                                                                                                                                                    Researcher(s)

                                                                                                                                                                                                                                    Research team(s)

                                                                                                                                                                                                                                      Economic evaluation of hepatitis A vaccination for military people in the Netherlands. 01/01/1994 - 30/06/1994

                                                                                                                                                                                                                                      Abstract

                                                                                                                                                                                                                                      In this economic evaluation, expressed in cost-effectiveness ratio, cost-benefit and cost-utility analysis, 4 different preventive strategies for hepatitis A vaccination for military people in the Netherlands will be compared. Several scenarios will be modeled in order to calculate the impact of some variables in a sensitivy analysis.

                                                                                                                                                                                                                                      Researcher(s)

                                                                                                                                                                                                                                      Research team(s)

                                                                                                                                                                                                                                        A dubbel-blind clinical study among infants in order to assess the reactogenicity and immunogenicity of three lots oral polio vaccine (produced in MRC5 cells). 01/11/1993 - 31/10/1995

                                                                                                                                                                                                                                        Abstract

                                                                                                                                                                                                                                        A new production technique for polio vaccines has been developed. A clinical trial among infants has been carried out to assess the reactogenicity and immunogenicity of this candidate-vaccine.

                                                                                                                                                                                                                                        Researcher(s)

                                                                                                                                                                                                                                        Research team(s)

                                                                                                                                                                                                                                          A dubbel-blind clinical study on the immunogenicity and reactogenicity of three different lots of a combined hepatitis A and B vaccine. 01/10/1993 - 30/09/1994

                                                                                                                                                                                                                                          Abstract

                                                                                                                                                                                                                                          A clinical trial with a combined hepatitis A and B vaccine is carried out in order to examine the immunogenicity and reactogenicity of this candidate vaccine.

                                                                                                                                                                                                                                          Researcher(s)

                                                                                                                                                                                                                                          Research team(s)

                                                                                                                                                                                                                                            Vaccine-trial, testing a new seed of yeast for recombinant hepatitis B vaccine production. 15/07/1993 - 14/06/1994

                                                                                                                                                                                                                                            Abstract

                                                                                                                                                                                                                                            Recombinant hepatitis B vaccines are produced using genetic engineering techniques, based on mammarian cell-line or on yeast. In this trial, a recombinant hepatitis B vaccine is used; the production of this vaccine is based on a second yeast-type. In this trial (n=150) the reactogenicity are measured, in a population of healthy volunteers.

                                                                                                                                                                                                                                            Researcher(s)

                                                                                                                                                                                                                                            Research team(s)

                                                                                                                                                                                                                                              Sero-epidemiological survey on hepatitis A, B en C among the Flemish population in Belgium. 01/03/1993 - 28/02/1994

                                                                                                                                                                                                                                              Abstract

                                                                                                                                                                                                                                              In order to have a recent and clear idea of the hepatitis A, B and C epidemiology in the Flanders (Belgium), a sero-epidemiological study is performed with the collaboration of 15 different hospitals. 5000 persons of all ages will be recruited for this prevalence-study. The results could influence the actual vaccination policy.

                                                                                                                                                                                                                                              Researcher(s)

                                                                                                                                                                                                                                              Research team(s)

                                                                                                                                                                                                                                                Sero-epidemiological survey on hepatitis A, B en C among the Flemish population in Belgium. 01/03/1993 - 15/12/1993

                                                                                                                                                                                                                                                Abstract

                                                                                                                                                                                                                                                In order to have a recent and clear idea of the hepatitis A, B and C epidemiology in the Flanders (Belgium), a sero-epidemiological study is performed with collaboration of 15 different hospitals. 5000 persons will be recruited for prevalence-study. The results could well influence the actual vaccination policy.

                                                                                                                                                                                                                                                Researcher(s)

                                                                                                                                                                                                                                                Research team(s)

                                                                                                                                                                                                                                                  Research on the epidemiology of HIV and HIV-related problems among adoptive children. 01/01/1993 - 31/03/1994

                                                                                                                                                                                                                                                  Abstract

                                                                                                                                                                                                                                                  In a first phase, in collaboration with the Aids platform in Antwerp, foreign adoptive children are screened for HIV, and the parents are counseled. This study is part of a larger research on adoption related health problems. In a second phase, a project will start to support and help parents with a HIV-positive child.

                                                                                                                                                                                                                                                  Researcher(s)

                                                                                                                                                                                                                                                  Research team(s)

                                                                                                                                                                                                                                                    Multicentre European seroprevalence study on hepatitis A in health care workers. 01/01/1993 - 31/12/1993

                                                                                                                                                                                                                                                    Abstract

                                                                                                                                                                                                                                                    In order to evaluate the occupational risk of hepatitis A infections among health care workers, a multicenter study is performed. Together with the seroprevalence data, epidemiological data are collected to look for an eventual association with hepatitis A prevalence. The study is performed in Antwerpen, Lyon, Freiburg and Manchester.

                                                                                                                                                                                                                                                    Researcher(s)

                                                                                                                                                                                                                                                    Research team(s)

                                                                                                                                                                                                                                                      Sero-epidemiological study of hepatitis B among prison wardens in Belgium. 01/10/1992 - 31/03/1994

                                                                                                                                                                                                                                                      Abstract

                                                                                                                                                                                                                                                      In order to measure the occupational risk of hepatitis B infection among prison guards, a sero-epidemiological study has been performed in all prisons in Belgium. In a second plan all seronegative warders (voluntary) will be vaccinated against hepatitis B.

                                                                                                                                                                                                                                                      Researcher(s)

                                                                                                                                                                                                                                                      Research team(s)

                                                                                                                                                                                                                                                        Clinical trial evaluating the double strength hepatitis A vaccin (1440 I.U.). 01/06/1992 - 31/05/1993

                                                                                                                                                                                                                                                        Abstract

                                                                                                                                                                                                                                                        The reactogenicity, immunogenicity and protective efficacy of the hepatitis A vaccine is well-documented. The actual vaccination schedule of 0-1 and 12 months gives a lower compliance for the second and third dose. In order to increase the compliance a one dose primary course was suggested : the double strength clinical trial has a one dose primary course (=month 0) followed by a booster at month 6 or 12. For the moment, we finalize the analysis of the reactogenicity and immunogenicity data.

                                                                                                                                                                                                                                                        Researcher(s)

                                                                                                                                                                                                                                                        Research team(s)

                                                                                                                                                                                                                                                          Horizontal transmission of hepatitis B. 01/01/1990 - 31/12/1990

                                                                                                                                                                                                                                                          Abstract

                                                                                                                                                                                                                                                          Study of horizontal transmission of hepatitis B.

                                                                                                                                                                                                                                                          Researcher(s)

                                                                                                                                                                                                                                                          Research team(s)