MVI has established preferred product characteristics (PPCs) for two malaria vaccine development programs: anti-infection vaccines (AIVs) and transmission-blocking vaccines (TBVs). The following PPCs are associated with the two programs:
Anti-infection vaccines (AIVs)
The AIV PPC describes a vaccine, based on pre-erythrocytic-stage immunogens, that elicits a high degree of protection against human infection by infected mosquitoes and that is used in conjunction with other malaria control measures for elimination of the parasite and prevention of reintroduction.
Transmission-blocking vaccines (TBVs)
The TBV PPC describes a vaccine that elicits immune responses to sexual and sporogonic stages of parasite growth antigens and mosquito antigens to prevent parasite transmission from infected humans to mosquitoes and to prevent development of the parasite in mosquitoes. The vaccine is used in conjunction with other malaria control measures for elimination of the parasite and prevention of reintroduction.
While our PPCs are subject to review and revision as the development process progresses, they are in general alignment with the PPCs proposed by the World Health Organization (WHO). One exception is the efficacy endpoint in the AIV approach: Consistent with our focus on elimination and eradication, we propose an efficacy measure for infection, whereas WHO’s PPC pursues an endpoint for prevention of disease. In addition, while our approaches currently target potential malaria-transmitting people of all age groups, WHO focuses on infants and children five years and younger.
MVI will generate target product profiles (TPPs) as we achieve proof of concept for our vaccine approaches in Phase 2 clinical studies. These TPPs will be more closely defined than our PPCs, and we will use them, in alignment with WHO, to ensure that our vaccine candidates possess all the characteristics required to be deemed suitable for prequalification.