• Lancet · Oct 2004

    Randomized Controlled Trial Multicenter Study Clinical Trial

    Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial.

    • Pedro L Alonso, Jahit Sacarlal, John J Aponte, Amanda Leach, Eusebio Macete, Jessica Milman, Inacio Mandomando, Bart Spiessens, Caterina Guinovart, Mateu Espasa, Quique Bassat, Pedro Aide, Opokua Ofori-Anyinam, Margarita M Navia, Sabine Corachan, Marc Ceuppens, Marie-Claude Dubois, Marie-Ange Demoitié, Filip Dubovsky, Clara Menéndez, Nadia Tornieporth, W Ripley Ballou, Ricardo Thompson, and Joe Cohen.
    • Centre de Salut Internacional, Hospital Clínic/IDIBAPS, Universitat de Barcelona, Barcelona, Spain. palonso@clinic.ub.es
    • Lancet. 2004 Oct 16; 364 (9443): 141114201411-20.

    BackgroundDevelopment of an effective malaria vaccine could greatly contribute to disease control. RTS,S/AS02A is a pre-erythrocytic vaccine candidate based on Plasmodium falciparum circumsporozoite surface antigen. We aimed to assess vaccine efficacy, immunogenicity, and safety in young African children.MethodsWe did a double-blind, phase IIb, randomised controlled trial in Mozambique in 2022 children aged 1-4 years. The study included two cohorts of children living in two separate areas which underwent different follow-up schemes. Participants were randomly allocated three doses of either RTS,S/AS02A candidate malaria vaccine or control vaccines. The primary endpoint, determined in cohort 1 (n=1605), was time to first clinical episode of P falciparum malaria (axillary temperature > or =37.5 degrees C and P falciparum asexual parasitaemia >2500 per microL) over a 6-month surveillance period. Efficacy for prevention of new infections was determined in cohort 2 (n=417). Analysis was per protocol.Findings115 children in cohort 1 and 50 in cohort 2 did not receive all three doses and were excluded from the per-protocol analysis. Vaccine efficacy for the first clinical episodes was 29.9% (95% CI 11.0-44.8; p=0.004). At the end of the 6-month observation period, prevalence of P falciparum infection was 37% lower in the RTS,S/AS02A group compared with the control group (11.9% vs 18.9%; p=0.0003). Vaccine efficacy for severe malaria was 57.7% (95% CI 16.2-80.6; p=0.019). In cohort 2, vaccine efficacy for extending time to first infection was 45.0% (31.4-55.9; p<0.0001).InterpretationThe RTS,S/AS02A vaccine was safe, well tolerated, and immunogenic. Our results show development of an effective vaccine against malaria is feasible.

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