A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants.

RTS,S Clinical Trials Partnership, ; Agnandji, ST; Lell, B; Fernandes, JF; Abossolo, BP; Methogo, BG; Kabwende, AL; Adegnika, AA; Mordmüller, B; Issifou, S; Kremsner, PG; Sacarlal, J; Aide, P; Lanaspa, M; Aponte, JJ; Machevo, S; Acacio, S; Bulo, H; Sigauque, B; Macete, E; Alonso, P; Abdulla, S; Salim, N; Minja, R; Mpina, M; Ahmed, S; Ali, AM; Mtoro, AT; Hamad, AS; Mutani, P; Tanner, M; Tinto, H; D'Alessandro, U; Sorgho, H; Valea, I; Bihoun, B; Guiraud, I; Kaboré, B; Sombié, O; Guiguemdé, RT; Ouédraogo, JB; Hamel, MJ; Kariuki, S; Oneko, M; Odero, C; Otieno, K; Awino, N; McMorrow, M; Muturi-Kioi, V; Laserson, KF; Slutsker, L; Otieno, W; Otieno, L; Otsyula, N; Gondi, S; Otieno, A; Owira, V; Oguk, E; Odongo, G; Woods, JB; Ogutu, B; Njuguna, P; Chilengi, R; Akoo, P; Kerubo, C; Maingi, C; Lang, T; Olotu, A; Bejon, P; Marsh, K; Mwambingu, G; Owusu-Agyei, S; Asante, KP; Osei-Kwakye, K; Boahen, O; Dosoo, D; Asante, I; Adjei, G; Kwara, E; Chandramohan, D; Greenwood, B; Lusingu, J; Gesase, S; Malabeja, A; Abdul, O; Mahende, C; Liheluka, E; Malle, L; Lemnge, M; Theander, TG; Drakeley, C; Ansong, D; Agbenyega, T; Adjei, S; Boateng, HO; Rettig, T; Bawa, J; Sylverken, J; Sambian, D; Sarfo, A; Agyekum, A; Martinson, F; Hoffman, I; Mvalo, T; Kamthunzi, P; Nkomo, R; Tembo, T; Tegha, G; Tsidya, M; Kilembe, J; Chawinga, C; Ballou, WR; Cohen, J; Guerra, Y; Jongert, E; Lapierre, D; Leach, A; Lievens, M; Ofori-Anyinam, O; Olivier, A; Vekemans, J; Carter, T; Kaslow, D; Leboulleux, D; Loucq, C; Radford, A; Savarese, B; Schellenberg, D; Sillman, M; Vansadia, P; (2012) A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants. The New England journal of medicine, 367 (24). pp. 2284-95. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa1208394

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: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial.<br/> : We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed.<br/> : The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222).<br/> : The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.).<br/>

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
Faculty of Infectious and Tropical Diseases > Dept of Immunology and Infection
Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Malaria Centre
PubMed ID: 23136909
Web of Science ID: 312187700002
URI: http://researchonline.lshtm.ac.uk/id/eprint/427472


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