SGS CPU, Belgium, and Vaccinopolis, University of Antwerp (UAntwerp), Belgium, are collaborating on human challenge trials. As two centers of expertise for conducting clinical trials, SGS CPU and Vaccinopolis have the facilities and knowledge to perform controlled human infection model (CHIM) studies.
Addressing the challenges
Human challenge trials play a pivotal role in the development of novel therapeutics and vaccines. However, some questions on operational aspects, ethics and regulatory considerations remain. With CHIMs, the main challenges are the availability, source and origin of the pathogenic strains, the production, 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.
To prefer implementing human challenge trials in early stages of the development of medication, means clearly defined rules and criteria for the challenge strains and models used. Discussion with the various stakeholders, including the regulatory agencies, is essential for success.
Identifying potential constraints for future human challenge trials
SGS CPU and Vaccinopolis have initiated a project aimed at identifying various, potential constraints for future human challenge trials. Together, they are generating a roadmap of challenge organisms and their respective benefits/hurdles and status. This will be used as a guideline for future discussions with the competent authorities, the pharmaceutical and biotech industries, and other stakeholders.
Prof. Pierre Van Damme, Head of Vaccinopolis, said: “We are excited about the collaboration with SGS. It will be a starting position to work on the standardization of human challenge strains with the ambition to accelerate the development of novel vaccines and therapeutics.”
Dr Annick van Riel, Director of SGS CPU, said: “This collaboration puts Antwerp on the map as CHIM hub: two neighboring, well-established organizations, with state-of-the-art, complementary facilities, partnering to support authorities, pharmaceutical and biotech companies in their process towards pandemic preparedness.”
This project is subsidized through the Relance Plan project from the Flemish Government.
SGS’s full range of health science services
SGS’s global network of analytical testing, formulation, clinical research, and clinical manufacturing solutions offer a wide range of integrated services and expertise. SGS experts are ready to support customers throughout the development and commercial manufacture of their drug products, helping ensure the delivery of safe, effective, and compliant medicines to global markets.
We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.
SGS Clinical Research has more than 40 years’ experience in offering clinical research services and bioanalytical testing for phase I to IV clinical trials, with a specialization in infectious diseases, respiratory diseases and vaccines.
The SGS CPU in Belgium specializes 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.
For further information, please contact:
Jelle Klein, MD, BHS
SGS Health Science - Medical Director
t: + 32 (0)3 217 21 72