title: Clinical development of RTS,S/AS malaria vaccine: a systematic review of clinical Phase I-III trials.
abstract: The first clinical Phase III trial evaluating a malaria vaccine was completed in December 2013 at 11 sites from seven sub-Saharan African countries. This systematic review assesses data of Phase I-III trials including malaria-naive adults and adults, children and infants from malaria endemic settings in sub-Saharan Africa. The main endpoint of this systematic review was an analysis of the consistency of efficacy and immunogenicity data from respective Phase I-III trials. In addition, safety data from a pooled analysis of RTS/AS Phase II trials and RTS,S/AS01 Phase III trial were reviewed. The RTS,S/AS01 malaria vaccine may become available on the market in the coming year. If so, further strategies should address challenges on how to optimize vaccine efficacy and implementation of RTS,S/AS01 vaccine within the framework of established malaria control measures.
authors.affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.|Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.
authors.forename: Selidji T
authors.initials: ST
authors.lastname: Agnandji
authors.affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.|Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.
authors.forename: José F
authors.initials: JF
authors.lastname: Fernandes
authors.affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.|Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.
authors.forename: Emmanuel B
authors.initials: EB
authors.lastname: Bache
authors.affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.|Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.|Department of Medicine I, Division of Infectious Diseases & Tropical Medicine, Medical University of Vienna, Austria, Währinger Gürtel 18-20, 1190 Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Ramharter
mesh_terms: D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D017780:Malaria Vaccines / Q000009:adverse effects / Q000276:immunology*; D016778:Malaria, Falciparum / Q000453:epidemiology* / Q000276:immunology / Q000401:mortality / Q000517:prevention & control*; D010963:Plasmodium falciparum / Q000276:immunology*; D014611:Vaccination
chemical_list: D017780:Malaria Vaccines
keywords: AS01; AS02; RTS,S/AS; anti-CSP; anti-HBs; geometric mean concentration; immune responses; vaccine efficacy