Agnandji Selidji T, Fernandes José F, Bache Emmanuel B, Ramharter Michael
Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Hôpital Albert Schweitzer BP 118, Lambaréné, Gabon.
Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany, Wilhelmstraße 27, 72074 Tübingen, Germany.
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.
2013年12月，在撒哈拉以南非洲7个国家的11个地点完成了评估疟疾疫苗的首个临床III期试验。本系统评价评估了I - III期试验的数据，这些试验涉及撒哈拉以南非洲疟疾流行地区的未感染疟疾的成年人以及成年人、儿童和婴儿。本系统评价的主要终点是分析各I - III期试验中疗效和免疫原性数据的一致性。此外，还回顾了RTS/AS II期试验和RTS,S/AS01 III期试验汇总分析的安全性数据。RTS,S/AS01疟疾疫苗可能在明年上市。如果是这样，进一步的策略应解决如何在既定疟疾控制措施框架内优化疫苗疗效和RTS,S/AS01疫苗实施方面的挑战。
