Future Microbiology
Posted online on October 6, 2015.
(doi:10.2217/fmb.15.90)
Clinical development of RTS, S/AS malaria vaccine: a systematic review of clinical Phase I-III trials
Selidji T Agnandji*,1,2, José F Fernandes1,2, Emmanuel B Bache1,2 & Michael Ramharter1,2,3
Summary
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.