Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children:: single-blind extended follow-up of a randomised controlled trial
Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children:: single-blind extended follow-up of a randomised controlled trial
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DOI：
10.1016/s0140-6736(05)67669-6
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发表时间：
2005-12-10
期刊：
影响因子：
168.9
通讯作者：
Ballou, WR
中科院分区：
文献类型：
--
作者：
Alonso, PL;Sacarlal, J;Ballou, WR
RTS，S/AS 02 A是一种红细胞前期疟疾疫苗，可在未感染疟疾的成年志愿者和超免疫成年人中提供部分抗感染保护。此前的一份报告显示，这种疫苗降低了临床疟疾的风险，推迟了新感染的时间，并减少了非洲儿童6个月以上的严重疟疾发作。一个重要的剩余问题是持久性的保护对临床疾病在these children.Methods我们做了一个随机，对照，IIb期试验RTS，S/AS 02 A在0，1，2个月在2022莫桑比克儿童1-4岁。我们以前确定了疫苗的疗效（VE）对临床疟疾的双盲阶段，包括研究月2.5-8.5（VE 2 5-8 5）。我们现在在单盲期报告VE，直至第21个月（VE 8 5-21）。主要终点是通过被动病例检测系统检测到恶性疟原虫疟疾首次或唯一临床发作的时间（腋温>= 37.5 ℃和恶性疟原虫无性寄生虫血症>2500/μ L）。我们还确定了其他病例定义和严重疟疾发作的VE。该研究注册于ClinicalTrials.gov，标识符为NCT 00197041。结果在单盲期，VE（8 5-21）为28.9%（95%CI 8.4-44.8; p=0.008）。在第21个月，RTS，S/AS 02 A组的恶性疟原虫感染率比对照组低29%（p=0.017）。考虑到整个研究期间，VE（25 -21）为35.3%（95%CI 21.6-46.6; p
Background RTS,S/AS02A is a pre-erythrocytic stage malaria vaccine that provides partial protection against infection in malaria-naive adult volunteers and hyperimmune adults. A previous report showed that this vaccine reduced risk of clinical malaria, delayed time to new infection, and reduced episodes of severe malaria over 6 months in African children. An important remaining issue is the durability of protection against clinical disease in these children.Methods We did a randomised, controlled, phase IIb trial of RTS,S/AS02A given at 0, 1, and 2 months in 2022 Mozambican children aged 1-4 years. We previously determined vaccine efficacy (VE) against clinical malaria in a double-blind phase that included study months 2.5-8.5 (VE2 5-8 5). We now report VE in a single-blind phase up to month 21 (VE8 5-21). The primary endpoint was time to first or only clinical episode of Plasmodium falciparum malaria (axillary temperature >= 37.5 degrees C and P falciparum asexual parasitaemia >2500 per mu L) detected through a passive case detection system. We also determined VE for other case definitions and for episodes of severe malaria. This study is registered with the ClinicalTrials.gov identifier NCT00197041.Findings During the single-blind phase, VE(8 5-21) was 28.9% (95% CI 8.4-44.8; p=0.008). At month 21, prevalence of P falciparum infection was 29% lower in the RTS,S/AS02A group than in the control (p=0.017). Considering the entire study period, VE(2 5-21) was 35.3% (95% CI 21.6-46.6; p