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Future Microbiol. 2015;10(10):1553-78. doi: 10.2217/fmb.15.90. Epub 2015 Oct 6.

Clinical development of RTS,S/AS malaria vaccine: a systematic review of clinical Phase I-III trials.

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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.


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.


AS01; AS02; RTS,S/AS; anti-CSP; anti-HBs; geometric mean concentration; immune responses; vaccine efficacy

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