Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
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DOI：
10.1056/nejmoa1609462
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发表时间：
2017-03-23
影响因子：
158.5
通讯作者：
Grais, Rebecca F.
中科院分区：
文献类型：
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作者：
Isanaka, Sheila;Guindo, Ousmane;Grais, Rebecca F.
背景每年，轮状病毒胃肠炎造成全球 5 岁以下儿童腹泻死亡的约 37%，在撒哈拉以南非洲地区影响尤为严重。方法我们在尼日尔进行了一项随机、安慰剂对照试验，以评估口服牛轮状病毒五价活疫苗（BRV-PV、血清）的功效。 印度研究所）预防严重轮状病毒胃肠炎。健康婴儿在 6、10 和 14 周龄时接受了三剂疫苗或安慰剂。通过主动和被动监测对胃肠炎发作进行评估，并根据 Vesikari 量表评分（范围从 0 到 20，评分越高表明疾病越严重）进行分级。主要终点是与安慰剂相比，三剂疫苗对第 3 剂疫苗后 28 天开始的实验室确诊的严重轮状病毒胃肠炎（Vesikari 评分，>= 11）首次发作的疗效。 结果 在纳入符合方案疗效分析的 3508 名婴儿中，疫苗组有 31 例严重轮状病毒胃肠炎，疫苗组有 87 例。 安慰剂组（每 100 人年分别有 2.14 例和 6.44 例病例），疫苗效力为 66.7%（95% 置信区间 [CI]，49.9 至 77.9）。意向治疗分析也显示出类似的功效，显示疫苗功效为 69.1%（95% CI，55.0 至 78.7）。不良事件风险（疫苗组 68.7% 的婴儿和安慰剂组 67.2% 的婴儿）或严重不良事件的风险（疫苗组 8.3% 和安慰剂组 9.1%）没有显着组间差异；疫苗组有 27 人死亡，安慰剂组有 22 人死亡。所有婴儿均未确诊肠套叠。结论三剂口服轮状病毒疫苗BRV-PV对尼日尔婴儿严重轮状病毒胃肠炎的有效率达66.7%。
BACKGROUNDEach year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa.METHODSWe conducted a randomized, placebo-controlled trial in Niger to evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV, Serum Institute of India) to prevent severe rotavirus gastroenteritis. Healthy infants received three doses of the vaccine or placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis were assessed through active and passive surveillance and were graded on the basis of the score on the Vesikari scale (which ranges from 0 to 20, with higher scores indicating more severe disease). The primary end point was the efficacy of three doses of vaccine as compared with placebo against a first episode of laboratory-confirmed severe rotavirus gastroenteritis (Vesikari score, >= 11) beginning 28 days after dose 3.RESULTSAmong the 3508 infants who were included in the per-protocol efficacy analysis, there were 31 cases of severe rotavirus gastroenteritis in the vaccine group and 87 cases in the placebo group (2.14 and 6.44 cases per 100 person-years, respectively), for a vaccine efficacy of 66.7% (95% confidence interval [CI], 49.9 to 77.9). Similar efficacy was seen in the intention-to-treat analyses, which showed a vaccine efficacy of 69.1% (95% CI, 55.0 to 78.7). There was no significant between-group difference in the risk of adverse events, which were reported in 68.7% of the infants in the vaccine group and in 67.2% of those in the placebo group, or in the risk of serious adverse events (in 8.3% in the vaccine group and in 9.1% in the placebo group); there were 27 deaths in the vaccine group and 22 in the placebo group. None of the infants had confirmed intussusception.CONCLUSIONSThree doses of BRV-PV, an oral rotavirus vaccine, had an efficacy of 66.7% against severe rotavirus gastroenteritis among infants in Niger.