MICA: An evaluation of the antimalarial vaccine candidateR21/matrix M for malaria elimination strategy in the Greater Mekong Subregion

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We are proposing the evaluation of the new vaccine candidate R21 with matrix-M adjuvant as a malaria elimination tool for the Greater Mekong Subregion. Existing malaria control tools have driven falciparum malaria transmission to very low levels. The addition of mass drug administrations has reduced and even interrupted transmission for short time spans. A vaccine which can confer protection for a longer, albeit limited, time period may be sufficient to interrupt malaria transmission permanently on a regional level.To roll out mass vaccine administrations on a regional level it is necessary to demonstrate that vaccine is well tolerated and triggers the desired immune response when co-administered with antimalarial drugs in the the people currently at risk for malaria in the Greater Mekong Subregion. We propose here a healthy volunteer study to demonstrate that the vaccine candidate R21 with matrix-M is well tolerated and immunogenic in Thailand. This study will be conducted in healthy volunteers at Mahidol University, Bangkok, Thailand. The vaccine regimen will consist of three vaccine doses one month apart. Each vaccine dose will be combined with three doses of antimalarial drugs (dihydroartemisinin / piperaquine and a single low dose primaquine). Study participants will be followed for 6 months to assess their well being and immune responses.If successful we will proceed to the next, larger trial to see whether the vaccine co-administered with antimalarial drugs protects against falciparum malaria, but that will be separate grant application.