Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.
N Engl J Med. 2010 Jan 28;362(4):289-98. doi: 10.1056/NEJMoa0904797.
Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children.
We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine--the pooled vaccine group--or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale.
A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group.
Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.)
轮状病毒是全世界导致婴幼儿严重胃肠炎的最常见原因。需要相关数据来评估轮状病毒疫苗在非洲儿童中的效果。
我们在南非（3166 名婴儿；占总数的 64.1%）和马拉维（1773 名婴儿；占总数的 35.9%）进行了一项随机、安慰剂对照、多中心试验，以评估口服活轮状病毒疫苗预防严重轮状病毒胃肠炎的效果。健康婴儿按 1:1:1 的比例随机分配接受两剂疫苗（此外还接受一剂安慰剂）或三剂疫苗——联合疫苗组——或在 6、10 和 14 周龄时接受三剂安慰剂。通过主动随访监测评估第一年由野生型轮状病毒引起的胃肠炎发作，并使用 Vesikari 量表进行分级。
共有 4939 名婴儿入组并随机分配至三组之一；1647 名婴儿接受两剂疫苗，1651 名婴儿接受三剂疫苗，1641 名婴儿接受安慰剂。在符合方案的疗效分析中，4417 名婴儿中有 4.9%的婴儿发生严重轮状病毒胃肠炎，联合疫苗组中有 1.9%的婴儿发生（疫苗有效率为 61.2%；95%置信区间为 44.0 至 73.2）。马拉维的疫苗效果低于南非（49.4%比 76.9%）；然而，马拉维预防严重轮状病毒胃肠炎的病例数高于南非（每 100 名接种疫苗的婴儿每年预防 6.7 例比 4.2 例）。对所有病因严重胃肠炎的疗效为 30.2%。联合疫苗组中 9.7%的婴儿和安慰剂组中 11.5%的婴儿报告至少发生了 1 起严重不良事件。
人轮状病毒疫苗显著降低了非洲婴儿在生命的第一年中严重轮状病毒胃肠炎的发病率。（临床试验注册编号，NCT00241644。）
