Abstract
Human challenge studies accelerate the development of prophylactic and curative treatments: with the use of Controlled Human Infectious Model (CHIM) studies, developers get a faster understanding of the "mechanism of action" and potential efficacy at an early stage of development. In addition, this method can also be used as a replacement for the large-scale phase 3 studies, which can be very difficult or not possible in some circumstances. This is e.g. the case for new 2nd and 3rd generation COVID vaccines and other infections, such as B. pertussis, where there is already a high vaccination coverage in the population. However, human challenge studies are complex and there is a lack of standardization. Both SGS and Vaccinopolis have experience and the capacity to conduct such complex studies, of course each with its own characteristics. Moreover, the organizations are complementary. To further highlight this strength, there is a joint interest and ambition to explore the future of human challenge trials by conducting a marketing study and setting up a collection of pathogenic strains (that can be used in such studies). This will allow to work out standardized protocols for the further development of these strains into a challenge agent as well as to reach a joint modus operandi between Vaccinopolis and SGS for setting up large studies. Consequently a unique setting can be offered towards capacity, knowledge, availability and standardization. Organizations as CEPI have already indicated their interest in such a concept and it is therefore the goal of SGS and Vaccinopolis to play an important role in this.
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