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

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


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.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Adult
  • Africa South of the Sahara / epidemiology
  • Child
  • Child, Preschool
  • Humans
  • Infant
  • Malaria Vaccines / adverse effects
  • Malaria Vaccines / immunology*
  • Malaria, Falciparum / epidemiology*
  • Malaria, Falciparum / immunology
  • Malaria, Falciparum / mortality
  • Malaria, Falciparum / prevention & control*
  • Plasmodium falciparum / immunology*
  • Vaccination


  • Malaria Vaccines