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Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger

机译：尼日尔低成本，热稳定口服轮状病毒疫苗的功效

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Background Each 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. Methods We 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. Results Among 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. Conclusions Three doses of BRV-PV, an oral rotavirus vaccine, had an efficacy of 66.7% against severe rotavirus gastroenteritis among infants in Niger. (Funded by Médecins sans Frontières Operational Center and the Kavli Foundation; ClinicalTrials.gov number, NCT02145000 .).
机译：背景技术每年轮状病毒胃肠炎占全世界5岁以下儿童腹泻死亡的约37％，在撒哈拉以南非洲的影响不成比例。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活体五价疫苗（BRV-PV，印度血清研究所）预防严重轮状病毒肠胃炎的疗效。健康的婴儿在6、10和14周龄接受了三剂疫苗或安慰剂。胃肠炎发作通过主动和被动监测进行评估，并根据Vesikari量表的评分（范围为0到20，评分越高，表明疾病越严重）进行分级。主要终点是在剂量3后28天开始，与安慰剂相比，三剂疫苗对实验室确诊的严重轮状病毒肠胃炎（Vesikari评分，≥11）的首发疗效。结果根据协议疗效分析，疫苗组有31例严重轮状病毒肠胃炎，安慰剂组有87例（分别为每100人年2.14和6.44例），疫苗的有效性为66.7％（95％）置信区间[CI]，49.9至77.9）。在意向治疗分析中看到了相似的功效，表明疫苗的功效为69.1％（95％CI，55.0至78.7）。不良事件发生风险的组间无显着性差异，据报道，疫苗组中68.7％的婴儿和安慰剂组中67.2％的婴儿，或发生严重不良事件的风险（8.3疫苗组中的百分比，安慰剂组中的9.1％）；疫苗组有27例死亡，安慰剂组有22例死亡。没有婴儿确认肠套叠。结论三剂口服轮状病毒疫苗BRV-PV在尼日尔婴儿中对重度轮状病毒肠胃炎的疗效为66.7％。 （由无国界医生行动中心和Kavli基金会资助； ClinicalTrials.gov编号，NCT02145000。）。

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