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Three doses of RTS,S/AS01, a candidate malaria vaccine, previously showed 28% efficacy against clinical malaria during 48 months of follow-up (NEJM JW Infect Dis Jun 2015 and Lancet 2015; 386:31). Investigators, with partial industry support, now report 7-year follow-up of 447 children randomly assigned at age 5 to 17 months to receive three doses of RTS,S/AS01 or rabies vaccine (control). The endpoint was clinical infection with Plasmodium falciparum.
In the intention-to-treat cohort, during the 7 years, overall vaccine efficacy was estimated to be 4.4%. Efficacy was 16.6% in the low-exposure group but was negative (−2.4%) in the high-exposure group. Vaccine efficacy waned over time and varied by level of malaria exposure. In the low-exposu…