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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in mozambican children
Journal of Infectious Diseases, Volume 200, No. 3, Year 2009
Notification
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Description
Background. We previously reported that the RTS,S/AS02A vaccine had an acceptable safety profile, was immunogenic, and demonstrated efficacy against Plasmodium falciparum malaria disease for 21 months. Methods. We conducted a randomized, controlled, phase 2b trial of RTS,S/AS02A in 2022 Mozambican children aged 1-4 years. We now report safety results for all randomized subjects and vaccine efficacy (VE) findings for children in the Manhiça area over the 45-month surveillance period. Results. During the surveillance period, the VE(2.5-45) (VE over months 2.5-45 of surveillance) against a first or only episode of clinical malaria disease was 30.5% (95% confidence interval [CI], 18.9%-40.4%; P< .001), and the VE (2.5-45) against all episodes was 25.6% (95% CI, 11.9%-37.1%; P< .001 ). When the same period was considered, the VE(2.5-45) for subjects protected against severe malaria was 38.3% (95% CI, 3.4%-61.3%; P = .045). At study month 45, the prevalence of P falciparum was 34% lower in the RTS,S/AS02A group than in the control group (66 [12.2%] of 541 patients vs 101 [18.5%] of 547 patients) (P = .004). Conclusion. These results show evidence that RTS,S/AS02A maintained protection during the 45-month surveillance period, and they highlight the feasibility of developing an effective vaccine against malaria. In combination with other malaria-control measures, such a vaccine could greatly contribute to reducing the intolerable global burden of this disease. © 2009 by the Infectious Diseases Society of America. All rights reserved.
Authors & Co-Authors
Sacarlal, J.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Universidade Eduardo Mondlane
Spain, Barcelona
Universitat de Barcelona
Spain, Barcelona
Instituto de Salud Global de Barcelona
Aíde, Pedro
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Universidade Eduardo Mondlane
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Renom, Montse
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Leach, Amanda
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Mandomando, Inácio M.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Universidade Eduardo Mondlane
Lievens, Marc J.J.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Bassat, Quique
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Lafuente, Sarah
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
MacEte, Eusébio V.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Vekemans, Johan
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Guinovart, Caterina
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Sigaúuque, Betuel
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Sillman, Marla
United States, Bethesda
Program for Appropriate Technology in Health
Milman, Jessica B.
United States, Bethesda
Program for Appropriate Technology in Health
Dubois, Marie Claude
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Demoitié, Marie Ange
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Thonnard, Joelle
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Menéndez, Clara
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Ballou, William Ripley
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Cohen, Joe D.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Alonso, Pedro Luís
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Statistics
Citations: 133
Authors: 22
Affiliations: 7
Identifiers
Doi:
10.1086/600119
ISSN:
00221899
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study