SGS CPU and Vaccinopolis (UAntwerp) announce a first collaboration in human challenge trials in Antwerp.
SGS CPU and Vaccinopolis are expertise centres for conducting clinical trials and moreover have the facilities and knowledge to perform controlled human infection model (CHIM) studies.
Although it is widely accepted that human challenge trials play a pivotal role in the development of novel therapeutics and vaccines, some open questions associated with operational aspects, ethics and regulatory considerations remain.
The main challenge in CHIMs concerns the availability, source and origin of the pathogenic strains, the production thereof, their quality and release criteria. The objective is to have several human challenge models and corresponding challenge agents generally accessible to both parties involved after this project.
Moreover, in order to implement human challenge trials in the development of medication, it is essential to clearly define the rules and criteria for the challenge strains and the human challenge models used. An open discussion with the various stakeholders, including the regulatory agencies, is essential for success.
SGS CPU and Vaccinopolis have initiated a project aimed at identifying various, potential constraints for future human challenge trials. Together, they target generating a roadmap of challenge organisms and their respective benefits/hurdles and current status, to be used as a guideline in the future discussion with the competent authorities, the pharmaceutical and biotech industries, and other stakeholders.
Prof. Pierre Van Damme, head of Vaccinopolis, comments: ‘We are excited about the collaboration with SGS. It will be a starting position to work on the standardisation of human challenge strains with the ambition to accelerate the development of novel vaccines and therapeutics.’
Dr Annick van Riel, director of SGS CPU, comments: ‘This collaboration puts Antwerp on the map as CHIM hub: two neighbouring, well-established organisations, with state-of-the-art, complementary facilities, partnering to support authorities, pharmaceutical and biotech companies in their process towards pandemic preparedness.’
This project is subsidised through the relance plan project from the Flemish Government.
As part of the SGS Belgium nv, Health Science division, SGS Clinical Research has more than 40 years of experience offering clinical research services and bioanalytical testing for phase I to IV clinical trials, with a specialisation in infectious diseases, respiratory diseases and vaccines.
SGS CPU is specialised in performing complex early phase clinical trials by testing therapeutic drugs and vaccines on healthy volunteers and small groups of patients. In its new 110-bed facility in Edegem, with on-site GMP Production Facility, human challenge trials are performed in two quarantine BSL-2 facilities (with 30 or 16 beds each) and dedicated laboratories.
Vaccinopolis is a new building from UAntwerp and has a unique 30-bed capacity under biosafety level-3 (BLS-3) conditions which allows it to perform human challenge studies with pathogens such as COVID. Next to the human challenge capability, the centre offers large BSL-2 and BSL-3 lab capacity as well as an ambulatory vaccine trial unit.