Format

Send to

Choose Destination
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.

Author information

1
Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.
2
Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.
3
Department of Medicine I, Division of Infectious Diseases & Tropical Medicine, Medical University of Vienna, Austria, Währinger Gürtel 18-20, 1190 Vienna, Austria.

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.

KEYWORDS:

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

PMID:
26437872
DOI:
10.2217/fmb.15.90
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center