Clinical development of RTS, S/AS malaria vaccine: a systematic review of clinical Phase I–III trials. (October 2015)

• Record Type: Journal Article
• Authors: Agnandji, Selidji T; Fernandes, José F; Bache, Emmanuel B; Ramharter, Michael
• Is Part Of: Future microbiology. Volume 10:Number 10(2015:Oct.)
• Page Start: 1553
• Page End: 1578
• Publication Date: 2015-10
• Subjects: anti-CSP -- anti-HBs -- AS01 -- AS02 -- geometric mean concentration -- immune responses -- RTS, S/AS -- vaccine efficacy; Microbiology -- Research -- Periodicals; 616.9041
• DOI: 10.2217/fmb.15.90
• Languages: English
• ISSNs: 1746-0913

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.