• Future microbiology · Jan 2015

    Review

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

    • Selidji T Agnandji, José F Fernandes, Emmanuel B Bache, and Michael Ramharter.
    • Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.
    • Future Microbiol. 2015 Jan 1; 10 (10): 1553-78.

    AbstractThe 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.

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