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Safety and immunogenicity of the RTS, S/AS02A candidate malaria vaccine in children aged 1­4 in Mozambique
Macete, E; Aponte, J. J; Guinovart, C; Sacarlal, J; Ofori-Anyinam, O; Mandomando, I; Espasa, M; Bevilacqua, C; Leach, A; Dubois, M C; Heppner, D G; Tello, L; Milman, J; Cohen, J; Dubovsky, F; Tornieporth, N; Thompson, R; Alonso, P. L.
Affiliation
  • Macete, E; Centro de Investigação em Saúde da Manhiça (CISM), Manhiça, Mozambique. Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain. Direccao Nacional de Saúde, Ministério de Saúde. Maputo. MZ
  • Aponte, J. J; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Maputo. MZ
  • Guinovart, C; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Maputo. MZ
  • Sacarlal, J; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Faculdade de Medicina, Universidade Eduardo Mandane. Maputo. MZ
  • Ofori-Anyinam, O; GlaxoSmithKline Biologicals. Rixensart. BE
  • Mandomando, I; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Instituto Nacional de Saúde, Ministério de Saúde. Maputo. MZ
  • Espasa, M; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Instituto Nacional de Saúde, Ministério de Saúde. Maputo. MZ
  • Bevilacqua, C; GlaxoSmithKline Biologicals. Rixensart. BE
  • Leach, A; GlaxoSmithKline Biologicals. Rixensart. BE
  • Dubois, M C; GlaxoSmithKline Biologicals. Rixensart. BE
  • Heppner, D G; Walter Reed Army Institute of Research. US
  • Tello, L; Centro de Investigação em Saúde da Manhiça (CISM). Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona. Maputo. MZ
  • Milman, J; Malaria Vaccine Initiative, Program for Appropriate Technology in Health. Maputo. MZ
  • Cohen, J; GlaxoSmithKline Biologicals. Rixensart. BE
  • Dubovsky, F; Malaria Vaccine Initiative, Program for Appropriate Technology in Health. Maputo. MZ
  • Tornieporth, N; GlaxoSmithKline Biologicals. Rixensart. BE
  • Thompson, R; Centro de Investigação em Saúde da Manhiça (CISM), Manhiça, Mozambique. Faculdade de Medicina, Universidade Eduardo Mandane. Instituto Nacional de Saúde, Ministério de Saúde. Maputo. MZ
  • Alonso, P. L; Centro de Investigação em Saúde da Manhiça (CISM), Manhiça, Mozambique. Centro de Salud Internacional, Hospital Clinic/ Institut d'Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain. GlaxoSmithKline Biologicals, Rixensart, Belgium . Instituto Nacional de Saúde, Ministério de Saúde, Maputo, Mozambique. Maputo. MZ
Trop. med. int. health ; 29(1): [37-46], Jan. 2007. ilus, tab, graf
Article in En | AIM, RSDM | ID: biblio-1526516
Responsible library: MZ1.1
ABSTRACT
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. 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 microg 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. Children were randomized to receive either RTS,S/AS02A or Engerix-B vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs). 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.
Subject(s)

Full text: 1 Collection: 06-national / MZ Database: AIM / RSDM Main subject: Malaria Vaccines / Hepatitis / Malaria Country/Region as subject: Africa Language: En Journal: Trop. med. int. health Year: 2007 Document type: Article

Full text: 1 Collection: 06-national / MZ Database: AIM / RSDM Main subject: Malaria Vaccines / Hepatitis / Malaria Country/Region as subject: Africa Language: En Journal: Trop. med. int. health Year: 2007 Document type: Article