In 2014, the MAL071 study showed in controlled human malaria infection (CHMI) that the delayed fractional dose regimen of RTS,S/AS01 achieved our target efficacy level of >80%.
This project (MAL092) is a follow-on Phase 2a CHMI study designed to bridge the pediatric formulation of RTS,S/AS01E to adults and to test alternative schedules that may be more optimal for elimination campaigns. This study will take place at the Walter Reed Army Institute of Research (WRAIR) and is the largest CHMI ever conducted with a target of 150 participants.
Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, et al.
A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria.
New England Journal of Medicine. 1997;336(2):86-91.
Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Krzych U, et al.
Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection.
The Journal of Infectious Diseases. 2009;200(3):337-346.
Regules JA, Cicatelli SB, Bennett JW, Paolino KM, Twomey PS, et al.
Fractional third and fourth dose of RTS,S/AS01 malaria candidate vaccine: a phase 2a controlled human malaria parasite infection and immunogenicity study.
The Journal of Infectious Diseases. 2016;214(5):762–771.
ClinicalTrials.gov Identifier: NCT03162614