Ebola

EBOVAC3: Open-label, Randomized, Clinical Trial to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo

Summary

The EBOVAC3 project aims to assess, through clinical trials in children and adults in Africa, the safety and effectiveness of an Ebola vaccine regimen. As such it will help to improve the world’s preparedness to deal with an Ebola outbreak. The project focuses on the ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) prime-boost’ Ebola vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost dose which is intended to enhance the immune response over time. Building on work carried out under the EBOVAC1 and 2 projects, EBOVAC3 will run clinical trials in children in Sierra Leone, Guinea and the Democratic Republic of Congo. It will also follow up people who participated in earlier clinical trials in Sierra Leone, to assess the safety and efficacy of the vaccine in the longer term. Finally, the project aims to characterize the outbreak preparedness of Sierra Leone, Guinea and the Democratic Republic of Congo.

Funding

The EBOVAC3 project has received funding from the IMI2 Joint Undertaking. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Coalition for Epidemic Preparedness Innovations (CEPI). For this trial, the Contract Research Organisation and part of the FANG ELISA analyses are funded by the CEPI. All other trial activities are funded by the IMI2 Joint Undertaking grant. All vaccines and neutralizing antibody level analyses against Ad26 at the first visit are provided by Janssen Vaccines & Prevention B.V. .

Role of GHI

UA coordinator: Pierre Van Damme

UA Co-coordintor: Jean-Pierre Van geertruyden

Researchers: Antea Paviotti and Kanchana Withanage

Doctoral students: Gwen Lemey, Ynke Larivière, Irene Garcia-Fogeda and Maha Saloum

Co-project managers: Gwen Lemey and Ynke Larivière

Administrative and financial coordinator: Paul Peter Vermeiren

Data Manager: Bernard Osang'ir

Personal assistant co-sponser: Nele Brusselaers

Partner(s)

University of Kinshasa, Janssen Vaccines & Prevention B.V., ACE Research and DFNet Research
External partners: The London School of Hygiene and Tropical Medicine (LSHTM), the Institut National de la Santé et de la Recherche Médicale (INSERM), and the College of Medicine and Allied Health Sciences (COMAHS)

Period

01/06/2018 - 31/05/2023

more information on EBOVAC3 website and IMI project portal

News of the EBOVAC3 team: ASTMH Annual Meeting 2023

Mid-October 2023 the in-person American Society of Tropical Medicine & Hygiene (ASTMH) Annual Meeting, aka #TropMed23, took place - just the second one since the COVID-19 pandemic. The GHI team went onsite and was able to present a wide variety of Global Health research output, via poster presentations, Young Investigator award presentations, as well as symposia.

For Ebovac 3:

First, Ynke Larivière and Gwen Lemey were invited to present during the Young Investigators Award session on Wednesday 15 October. They are both PhD students and project coordinators of the EBOVAC3 clinical trial, conducted by the University of Antwerp, the University of Kinshasa and Johnson & Johnson. It has been set up to evaluate the safety, tolerability and durability of the Johnson & Johnson Ebola vaccine regimen in healthcare providers and frontline workers in Boende, Democratic Republic of the Congo. Ynke presented the challenges, mitigations, and lessons learned when conducting this Ebola vaccine trial, whereas Gwen presented the results of the ancillary care policy evaluation developed for this trial.

Secondly, the following research was presented during the poster sessions:

Understanding vaccine trust and uptake in Boende, western DR Congo: a mixed-methods study by Maha Salloum. Maha is a PhD student who works on the community perceptions surrounding the Ebola vaccine and examining the attitudes and confidence in childhood vaccinations.

Low seroprevalence of Ebola virus in health care providers in an endemic region (Tshuapa province) of the Democratic Republic of the Congo, by Trésor Zola, who is exploring the iris scanning identification, and trial site and acceptability of the Ad26.ZEBOV, MVA-BN-Filo vaccination regimen among healthcare providers

Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo, also by Trésor Zola.

Community Engagement in Epidemic Management: An Analysis of the Ebola Virus Disease and COVID-19 Responses in Boende, western DR Congo, by Freddy Bikioli, who works on the experiences of the management of Ebola and Covid-19 to improve disease management in the DR Congo.

Conducting an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned, by Ynke Larivière.

Impact of an ancillary care policy during an Ebola vaccine trial in the Democratic Republic of the Congo, by Gwen Lemey.

Lastly, we also had the opportunity to organize a EBOVAC3 symposium, named Challenges and Solutions to Meet Sporadic Outbreaks of Deadly Pathogens in Resource - Limited Settings, chaired by Jean-Pierre Van geertruyden, head of the Global Health Institute. The following speakers and topics were included:

Prof. Shelley Lees (LSHTM) on Regulatory preparedness for the next outbreak in LMICs and the community’s understanding, expectations and acceptance;

Prof. Hypolite Mavoko-Muhindo (University of Kinshasa) on Epidemic preparedness through the assessment of vaccine durability in an endemic region and an at risk population (e.g. health care providers and frontliners) in the DRC;

Prof. Edward Choi (LSHTM) on Vaccine response in the most vulnerable populations (e.g. infants) in Sierra Leone and Guinea and its durability in children, adolescents and adults in Sierra Leone;

Prof. Eduard L’homme (Université de Bordeau) on The use of mathematical modelling for vaccine development: the example of Ebola;

Cynthia Robinson (Janssen Vaccines & Prevention) on Development path of the Janssen vaccine up to licensure and WHO prequalification.

The poster can be downloaded for your information: Poster Maha Salloum / Trésor Zola / Freddy Bikioli / Ynke Larivière / Gwen Lemey