A phase IIa, randomized, double-blind, safety, immunogenicity and efficacy trial of Plasmodium falciparum vaccine antigens merozoite surface protein 1 and RTS,S formulated with AS02 adjuvant in healthy, malaria-na ïve adults

CONCLUSION: Co-administration of RTS,S and FMP1/AS02 reduced anti-RTS,S antibody, but did not affect tolerability, cellular immunity, or efficacy in a stringent CHMI model. Absence of efficacy or delay of patency in the sporozoite challenge model in the FMP1/AS02 group did not rule out efficacy of FMP1/AS02 in an endemic population. However, a Phase IIb trial of FMP1/AS02 in children in malaria-endemic Kenya did not demonstrate efficacy against natural infection.CLINICALTRIALS: gov identifier: NCT01556945.PMID:38584058 | DOI:10.1016/j.vaccine.2024.03.072

Source: Vaccine - April 7, 2024 Category: Allergy & Immunology Authors: J F Cummings M E Polhemus K E Kester C F Ockenhouse R A Gasser P Coyne G Wortmann R K Nielsen K Schaecher C A Holland U Krzych N Tornieporth L A Soisson E Angov D G Heppner RTS,S Vaccine Evaluation Group Source Type: research