Cohen J, Benns S, Vekemans J, Leach A
GlaxoSmithKline Biologicals, rue de l'Institut 89, Rixensart, Belgium.
Ann Pharm Fr. 2010 Nov;68(6):370-9. doi: 10.1016/j.pharma.2010.07.002. Epub 2010 Oct 13.
This review paper describes the development of the RTS,S/AS vaccine, from concept to phase III testing. The rationale for selection of the circumsporozoite protein (CSP) as the target antigen and the preclinical development history of the vaccine are described. The RTS,S/AS candidate vaccine has been evaluated in multiple phase I/II studies and was shown to have a favorable safety profile and to be well tolerated in both adults and children. Consistent and significant efficacy has been observed in the target population of infants and children against Plasmodium falciparum infection and disease in different transmission settings, in different age groups, with or without Expanded Program of Immunization (EPI) vaccine co-administration. The RTS,S/AS01(E) malaria vaccine candidate has recently entered phase III testing. Reaching this important milestone is the culmination of more than 20 years of research and development by GlaxoSmithKline, their partners and collaborators. If the phase III results confirm the observations made during phase II testing, the RTS,S/AS01(E) vaccine, when broadly implemented and judiciously integrated with other malaria-prevention measures, would have a major public-health impact in sub-Saharan Africa.
这篇综述文章描述了RTS,S/AS疫苗从概念到III期试验的发展历程。文中阐述了选择环子孢子蛋白（CSP）作为靶抗原的基本原理以及该疫苗的临床前研发历史。RTS,S/AS候选疫苗已在多项I/II期研究中进行了评估，结果显示其安全性良好，在成人和儿童中均具有良好的耐受性。在不同传播环境、不同年龄组、无论是否联合扩大免疫规划（EPI）疫苗接种的情况下，均在婴幼儿目标人群中观察到针对恶性疟原虫感染和疾病的持续且显著的疗效。RTS,S/AS01(E)疟疾候选疫苗最近已进入III期试验。达到这一重要里程碑是葛兰素史克公司及其合作伙伴和协作者20多年研发工作的成果。如果III期试验结果证实II期试验期间的观察结果，那么RTS,S/AS01(E)疫苗在广泛实施并与其他疟疾预防措施合理整合后，将对撒哈拉以南非洲地区产生重大的公共卫生影响。
