Long-Term Safety and Efficacy of the RTS,S/AS02A Malaria Vaccine in Mozambican Children
Long-Term Safety and Efficacy of the RTS,S/AS02A Malaria Vaccine in Mozambican Children
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DOI：
10.1086/600119
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发表时间：
2009-08-01
影响因子：
6.4
通讯作者：
Alonso, Pedro L.
中科院分区：
文献类型：
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作者：
Sacarlal, Jahit;Aide, Pedro;Alonso, Pedro L.
背景。我们之前报道过RTS，S/AS02A疫苗具有可接受的安全性，具有免疫原性，并且对恶性疟原虫疟疾有21个月的疗效。我们在2022名1-4岁的莫桑比克儿童中进行了RTS，S/AS02A的随机、对照、2b期试验。我们现在报告所有随机受试者的安全性结果和马尼托巴地区儿童在45个月监测期间的疫苗效力（VE）结果。在监测期间，首次或唯一临床疟疾发作的VE(2.5-45)（监测期间2.5-45个月的VE）为30.5%(95%可信区间[CI]， 18.9%-40.4%
Background. We previously reported that the RTS,S/AS02A vaccine had an acceptable safety profile, was immunogenic, and demonstrated efficacy against Plasmodium falciparum malaria disease for 21 months.Methods. We conducted a randomized, controlled, phase 2b trial of RTS,S/AS02A in 2022 Mozambican children aged 1-4 years. We now report safety results for all randomized subjects and vaccine efficacy (VE) findings for children in the Manhic, a area over the 45-month surveillance period.Results. During the surveillance period, the VE (2.5-45) (VE over months 2.5-45 of surveillance) against a first or only episode of clinical malaria disease was 30.5% (95% confidence interval [CI], 18.9%-40.4%; P