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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial
Vaccine, Volume 26, No. 2, Year 2008
Notification
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Description
RTS,S/AS02A is a pre-erythrocytic vaccine candidate based on the Plasmodium falciparum circumsporozoite surface antigen and is currently the most advanced malaria vaccine candidate in development. A proof of concept phase IIb trial of the RTS,S/AS02A in Mozambican children aged 1-4 years determined a vaccine efficacy against risk of clinical malaria of 35.3% (95% CI 21.6-46.6; p < 0.0001) and against severe malaria of 48.6% (95% CI 12.3-71.0; p = 0.02). We evaluated the safety of the RTS,S/AS02A vaccine. 2022 children that received at least one vaccine dose of RTS,S/AS02A or control vaccines were included in the intention to treat safety analysis. Vaccine safety was evaluated using active and passive follow-up. Participants were observed for at least 1 h after each dose. Trained field workers visited children at home daily for the next 3 days to record solicited and unsolicited local and general symptoms. Investigators followed-up participants with severe adverse events until month 21. Overall, we recorded 1712 unsolicited adverse events after vaccination, 53% in the intervention and 47% in the control group. Most unsolicited adverse events reported with RTS,S/AS02A were self-limited, and participants recovered without sequelae. Local reactogenicity increased with the number of doses. The proportion of children experiencing serious adverse events was lower in the RTS,S/AS02A recipients compared to the control group (Engerix-B™ or Prevnar™ and Hiberix™). Overall, these results indicate that the RTS,S/AS02A vaccine has a good safety profile and well tolerated when given in three doses to semi-immune children living in malaria-endemic areas. © 2007 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Sacarlal, J.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Hospital Clinic Barcelona
Mozambique, Maputo
Universidade Eduardo Mondlane
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Hospital Clinic Barcelona
Aíde, Pedro
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saú
Mandomando, Inácio M.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saú
Bassat, Quique
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Hospital Clinic Barcelona
Guinovart, Caterina
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Hospital Clinic Barcelona
Leach, Amanda
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Milman, Jessica B.
United States, Bethesda
Path Malaria Vaccine Initiative
MacEte, Eusébio V.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saú
Espasa Soley, Mateu
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Hospital Clinic Barcelona
Ofori-Anyinam, Opokua
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Thonnard, Joelle
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Corachan, Sabine
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Dubois, Marie Claude
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Lievens, Marc J.J.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Dubovsky, Filip
United States, Bethesda
Path Malaria Vaccine Initiative
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
Hospital Clinic Barcelona
Statistics
Citations: 46
Authors: 19
Affiliations: 6
Identifiers
Doi:
10.1016/j.vaccine.2007.11.003
ISSN:
0264410X
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study