Efficacy of Phase 3 Trial of RTS, S/AS01 Malaria Vaccine in infants: a systematic review and meta-analysis.

Abstract

Although vaccines would be the ideal tool for control, prevention, elimination, and eradication of many infectious diseases, developing of parasites vaccines such as malaria vaccine is very complex. The most advanced malaria vaccine candidate is RTS,S, a pre-erythrocytic vaccine for which pivotal phase III trial design is underway. Few recent malaria vaccine review articles have attempted to outline of all clinical trials that have occurred globally and no meta-analysis was performed on efficacy of Phase 3 Trial of RTS, S/AS01 Malaria vaccine up to now in infants. Therefore, a systematic review and meta-analysis was carried out to review new and existing data on efficacy of Phase 3 Trial of RTS, S/AS01 Malaria Vaccine in infants. The electronic databases searched were Pubmed (1965-present) and Web of Science (1970-present) (Search date: May, 2016). After full-text review of the papers evaluating clinical/severe malaria in several well-designed phase III field efficacy trials, 5 were determined to meet the eligibility criteria for inclusion in the systematic review. Four out of the 5 publications dealing with efficacy of Phase 3 Trial of RTS, S/AS01 malaria vaccine were included in the qualitative analysis. Pooled estimate of vaccine efficacy in clinical and severe malaria in children aged 5-17mo was 29% (95% CL: 19%-46%) and 39% (95% CI 20%-74%), while this estimate vaccine in clinical and severe malaria in children aged 6-12mo was 19% (95% CI 14%-24%) and 21 (95% CI 19%-37%), respectively. On the other hand, higher VE was seen in both per- protocol and intention-to-treat population in children aged 5-17 than the children aged 6-12mo. The results of this meta-analysis suggest that this candidate malaria vaccine has relatively little efficacy, and the vaccine apparently will not meet the goal of malaria eradication by itself.