CHIMs in LMICs, a workshop to explore regulation and ethics (360G-Wellcome-208265_Z_17_Z)

Vaccines provide an efficient strategy to control infectious diseases in LMIC but the discovery pathway rarely involves the LMIC population at risk until Phase 3 clinical trial. Controlled human infection models offer a fast, effective, economic means to down-select vaccine candidates at Phase 2 and hence reduce the risk of Phase 3 failure. Vaccine target populations with endemic exposure to infectious pathogens (e.g. malaria), or a particular immunomodulatory challenge (nutrition, crowding, intense exposure, HIV infection) are likely to show different, and more relevant, results in CHIM studies. There are, however, key methodological, ethical and regulatory issues in the safe conduct of human infection models that must be addressed in any population before CHIM studies can be planned. The rationale for this workshop is to explore the particular methodological, ethical and regulatory issues associated with CHIM in Malawi.