Research in context
Evidence before this study
We did a systematic literature search between Dec 18, 2014, and Feb 20, 2015, of randomised controlled trials of RTS,S malaria vaccine on PubMed, the Cochrane Library, and other relevant data sources for the period 1984 to Jan 31, 2015. We searched PubMed using the Medical Subject Headings (MeSH) terms “RTS,S-AS01B vaccine”[All Fields] OR “RTS,S-AS01E vaccine”[All Fields] OR “RTS,S-AS02A vaccine”[All Fields] OR “RTS,S-AS02D vaccine”[All Fields] OR “RTS,S/AS01”[All Fields] OR “RTS,S/AS02”[All Fields] AND “clinical trial”[Publication Type] OR “clinical trials as topic”[MeSH Terms] OR “clinical trial”[All Fields] AND “humans”[MeSH Terms]. For the Cochrane Library and other data sources, we used the following key search terms: “RTS,S”, “malaria vaccines”, AND “clinical trials”. The 60 manuscripts identified included five that reported the results of randomised controlled trials with long-term safety or efficacy follow-up or booster dose, two pooled analyses, and two systematic reviews.
Added value of this study
This study provided additional information on the safety and long-term efficacy of RTS,S/AS01 in a large population of children across different malaria transmission settings. Additionally, the study showed how booster vaccination extended the period of protection provided by the vaccine.
Implications of all available evidence
The RTS,S malaria vaccine candidate has consistently shown protection against clinical malaria episodes in different age groups across different transmission settings. Vaccine efficacy has been shown with or without concurrent Expanded Program on Immunization vaccination. The vaccine has consistently shown a good safety profile, although a meningitis safety signal reported among older children will need further follow-up. The results of the present study show the potential public health benefit of the RTS,S vaccine as an additional means for malaria control whilst the next generation of malaria vaccines are being developed.