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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Safety and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in children aged 1-4 in Mozambique
Tropical Medicine and International Health, Volume 12, No. 1, Year 2007
Notification
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Description
Background: The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine. Objective: We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1-4 in Mozambique to evaluate the safety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 μg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population. Method: Children were randomized to receive either RTS,S/AS02A or Engerix-BU® vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs). Results: The RTS,S/AS02A was found to be safe and well tolerated. Serious adverse events were balanced between both groups and none was related to vaccination. The frequency of adverse events reported with RTS, S/AS02A was comparable to previous studies in children. Grade 3 AEs were infrequent (one case of pain, one of fever in each group and some swelling greater than 20 mm in diameter), transient and resolved without sequelae. RTS,S/AS02A was highly immunogenic for anti-circumsporozoite protein antibody response and induced a strong anti-hepatitis-B surface antigen response. © 2007 Blackwell Publishing Ltd.
Authors & Co-Authors
MacEte, Eusébio V.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Guinovart, Caterina
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Sacarlal, J.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Mozambique, Maputo
Universidade Eduardo Mondlane
Ofori-Anyinam, Opokua
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Mandomando, Inácio M.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Espasa Soley, Mateu
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Bevilacqua, C.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Leach, Amanda
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Dubois, Marie Claude
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Heppner, D. Gray
United States, Silver Spring
Walter Reed Army Institute of Research
Tello, L.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Milman, Jessica B.
United States, Seattle
Malaria Vaccine Initiative
Cohen, Joe D.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Dubovsky, Filip
United States, Seattle
Malaria Vaccine Initiative
Tornieporth, Nadia Gabriela
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Thompson, Ricardo Estevão
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Universidade Eduardo Mondlane
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Alonso, Pedro Luís
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Spain, Barcelona
Hospital Clinic Barcelona
Statistics
Citations: 50
Authors: 18
Affiliations: 8
Identifiers
Doi:
10.1111/j.1365-3156.2006.01754.x
ISSN:
13602276
e-ISSN:
13653156
Research Areas
Disability
Genetics And Genomics
Infectious Diseases
Maternal And Child Health
Study Design
Cross Sectional Study
Study Approach
Quantitative
Study Locations
Gambia
Mozambique