von Seidlein Lorenz, Hanboonkunupakarn Borimas, Jittmala Podjanee, Pukrittayakamee Sasithon
Mahidol-Oxford Research Unity, Bangkok, Thailand.
Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Emerg Top Life Sci. 2017 Dec 22;1(6):533-537. doi: 10.1042/ETLS20170101.
RTS,S/AS01 is the most advanced vaccine to prevent malaria. It is safe and moderately effective. A large pivotal phase III trial in over 15 000 young children in sub-Saharan Africa completed in 2014 showed that the vaccine could protect around one-third of children (aged 5-17 months) and one-fourth of infants (aged 6-12 weeks) from uncomplicated falciparum malaria. The European Medicines Agency approved licensing and programmatic roll-out of the RTSS vaccine in malaria endemic countries in sub-Saharan Africa. WHO is planning further studies in a large Malaria Vaccine Implementation Programme, in more than 400 000 young African children. With the changing malaria epidemiology in Africa resulting in older children at risk, alternative modes of employment are under evaluation, for example the use of RTS,S/AS01 in older children as part of seasonal malaria prophylaxis. Another strategy is combining mass drug administrations with mass vaccine campaigns for all age groups in regional malaria elimination campaigns. A phase II trial is ongoing to evaluate the safety and immunogenicity of the RTSS in combination with antimalarial drugs in Thailand. Such novel approaches aim to extract the maximum benefit from the well-documented, short-lasting protective efficacy of RTS,S/AS01.
RTS,S/AS01是预防疟疾的最先进疫苗。它安全且有一定疗效。2014年在撒哈拉以南非洲超过15000名幼儿中完成的一项大型关键III期试验表明，该疫苗可使约三分之一的儿童（5至17个月大）和四分之一的婴儿（6至12周大）免受非复杂性恶性疟原虫疟疾感染。欧洲药品管理局批准了RTSS疫苗在撒哈拉以南非洲疟疾流行国家的许可和计划推广。世卫组织正在计划在一个大型疟疾疫苗实施计划中对超过40万非洲幼儿开展进一步研究。随着非洲疟疾流行病学的变化，大龄儿童面临风险，正在评估其他使用方式，例如在大龄儿童中使用RTS,S/AS01作为季节性疟疾预防措施的一部分。另一种策略是在区域疟疾消除运动中，将针对所有年龄组的大规模药物给药与大规模疫苗接种运动相结合。泰国正在进行一项II期试验，以评估RTSS与抗疟药物联合使用的安全性和免疫原性。此类新方法旨在从RTS,S/AS01有充分记录的短期保护效力中获取最大益处。
