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

@article{citeulike:681482, abstract = {SummaryBackgroundDevelopment 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 >=37[middle dot]5[deg]C and P falciparum asexual parasitaemia >2500 per [mu]L) 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[middle dot]9\% (95\% CI 11[middle dot]0-44[middle dot]8; p=0[middle dot]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[middle dot]9\% vs 18[middle dot]9\%; p=0[middle dot]0003). Vaccine efficacy for severe malaria was 57[middle dot]7\% (95\% CI 16[middle dot]2-80[middle dot]6; p=0[middle dot]019). In cohort 2, vaccine efficacy for extending time to first infection was 45[middle dot]0\% (31[middle dot]4-55[middle dot]9; pInterpretationThe RTS,S/AS02A vaccine was safe, well tolerated, and immunogenic. Our results show development of an effective vaccine against malaria is feasible.}, author = {Alonso, Pedro L. and Sacarlal, Jahit and Aponte, John J. and Leach, Amanda and Macete, Eusebio and Milman, Jessica and Mandomando, Inacio and Spiessens, Bart and Guinovart, Caterina and Espasa, Mateu and Bassat, Quique and Aide, Pedro and Ofori-Anyinam, Opokua and Navia, Margarita M. and Corachan, Sabine and Ceuppens, Marc and Dubois, Marie-Claude and Demoiti\'{e}, Marie-Ange and Dubovsky, Filip and Men\'{e}ndez, Clara and Tornieporth, Nadia and Ballou, Ripley W. and Thompson, Ricardo and Cohen, Joe}, citeulike-article-id = {681482}, citeulike-linkout-0 = {http://dx.doi.org/10.1016/S0140-6736(04)17223-1}, citeulike-linkout-1 = {http://www.sciencedirect.com/science/article/B6T1B-4DK5VTF-12/2/32edbe59697d9ec5fd00924978936612}, doi = {10.1016/S0140-6736(04)17223-1}, journal = {The Lancet}, keywords = {africa, as02a, children, falciparum, malaria, malaria\_vaccine, plasmodium, rtss, vaccine}, number = {9443}, pages = {1411--1420}, posted-at = {2006-06-02 13:44:29}, priority = {2}, title = {Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial}, url = {http://dx.doi.org/10.1016/S0140-6736(04)17223-1}, volume = {364} }

TY - JOUR ID - citeulike:681482 L3 - citeulike-article-id:681482 N2 - SummaryBackgroundDevelopment 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 >=37[middle dot]5[deg]C and P falciparum asexual parasitaemia >2500 per [mu]L) 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[middle dot]9% (95% CI 11[middle dot]0-44[middle dot]8; p=0[middle dot]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[middle dot]9% vs 18[middle dot]9%; p=0[middle dot]0003). Vaccine efficacy for severe malaria was 57[middle dot]7% (95% CI 16[middle dot]2-80[middle dot]6; p=0[middle dot]019). In cohort 2, vaccine efficacy for extending time to first infection was 45[middle dot]0% (31[middle dot]4-55[middle dot]9; pInterpretationThe RTS,S/AS02A vaccine was safe, well tolerated, and immunogenic. Our results show development of an effective vaccine against malaria is feasible. IS - 9443 JF - The Lancet EP - 1420 TI - Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial VL - 364 SP - 1411 KW - africa KW - as02a KW - children KW - falciparum KW - malaria KW - malaria_vaccine KW - plasmodium KW - rtss KW - vaccine AU - Alonso, Pedro AU - Sacarlal, Jahit AU - Aponte, John AU - Leach, Amanda AU - Macete, Eusebio AU - Milman, Jessica AU - Mandomando, Inacio AU - Spiessens, Bart AU - Guinovart, Caterina AU - Espasa, Mateu AU - Bassat, Quique AU - Aide, Pedro AU - Ofori-Anyinam, Opokua AU - Navia, Margarita AU - Corachan, Sabine AU - Ceuppens, Marc AU - Dubois, Marie-Claude AU - Demoitié, Marie-Ange AU - Dubovsky, Filip AU - Menéndez, Clara AU - Tornieporth, Nadia AU - Ballou, Ripley AU - Thompson, Ricardo AU - Cohen, Joe UR - http://dx.doi.org/10.1016/S0140-6736(04)17223-1 ER -