Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial.
Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial.
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DOI：
10.1016/s0140-6736(13)62630-6
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发表时间：
2014-06-21
期刊：
影响因子：
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通讯作者：
India Rotavirus Vaccine Group
中科院分区：
文献类型：
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作者：
Bhandari N;Rongsen-Chandola T;Bavdekar A;John J;Antony K;Taneja S;Goyal N;Kawade A;Kang G;Rathore SS;Juvekar S;Muliyil J;Arya A;Shaikh H;Abraham V;Vrati S;Proschan M;Kohberger R;Thiry G;Glass R;Greenberg HB;Curlin G;Mohan K;Harshavardhan GV;Prasad S;Rao TS;Boslego J;Bhan MK;India Rotavirus Vaccine Group
轮状病毒是发展中国家严重脱水胃肠炎的最常见原因。发展中国家需要安全、有效和负担得起的轮状病毒疫苗。在一项双盲安慰剂对照的多中心试验中，6799名6至7周的婴儿随机接受了3剂口服人-牛天然重组疫苗(116E)或安慰剂，分别在6周、10周和14周。主要结果是严重的轮状病毒胃肠炎(≥11，韦斯卡里分级)。通过积极监测确定疗效、结果和不良事件。在分析中，中位年龄为17.2月；超过96%的受试者接种了所有三剂疫苗/安慰剂，约1%的受试者失去了随访。4532名和2267名受试者被随机分配，分别接受疫苗和安慰剂治疗。按方案进行的分析包括4354名疫苗受试者和2187名安慰剂组受试者。接种者4752人年报告重型轮状病毒胃肠炎71例，安慰剂组2360人年76例，出生后第1年疫苗有效率分别为53·6%(95%CI 35·0~66·9；P<；0·001)和56·4%(95%CI 36·6~70·1；P<；0·001)。预防一次严重轮状病毒胃肠炎发作需要接种疫苗的婴儿数为55例(95%可信区间37-97)。重型轮状病毒胃肠炎发病率疫苗组为1.5人年，安慰剂组为3.2人年，发病率比为0.46(95%CI为0.33~0.65)。重型轮状病毒胃肠炎的绝对减少率为1.7(95%可信区间为2.5~0.9)。对各种病因的重症胃肠炎的有效率分别为18.6%(95%CI 1·9~32·3)和24·1%(95%CI 5·8~38·7)。在两组患者中，即时的、主动的和严重的不良事件的发生率相似。4532名疫苗接种者中有6例发生肠套叠，2267名安慰剂者中有2例发生肠套叠(P=0.73)。所有肠套叠病例均发生在第三次注射后。在疫苗和安慰剂接受者中，给药和肠套叠之间的最短间隔分别为112天和36天。单价人-牛(116E)轮状病毒疫苗在印度婴儿中有效且耐受性良好。
Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed for developing countries. In a double-blind placebo controlled multicentre trial, 6799 infants aged 6 to 7 weeks were randomised to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. Primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. At analyses, the median age was 17·2 months; over 96% subjects received all three doses of the vaccine/placebo and ~1% were lost to follow up. 4532 and 2267 subjects were randomly assigned to receive vaccine and placebo, respectively. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. 71 events of severe rotavirus gastroenteritis were reported in 4752 person years among the vaccinees compared to 76 events in 2360 person years in the placebo recipients; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; P<0·001) and 56·4% (95% CI 36·6–70·1; P <0·001) in the first year of life. The number of infants needed to be immunized to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis/100 person years was 1·5 in vaccine and 3·2 in placebo group and an incidence rate ratio of 0·46 (95% CI 0·33–0·65). The absolute rate reduction for severe rotavirus gastroenteritis was 1·7 (95% CI 2·5–0·9). Efficacy against severe gastroenteritis of any aetiology was 18·6% (95% CI 1·9–32·3); it was 24·1% (95% CI 5·8–38·7) in the first year of life. The prevalence of immediate, solicited, and serious adverse events were similar in both groups. There were six cases of intussusception amongst 4532 vaccinees and two amongst 2267 placebo recipients (P=0·73). All intussusception cases occurred after the third dose. Among vaccine and placebo recipients, the minimum interval between dosing and intussusception was 112 and 36 days, respectively. The monovalent human-bovine (116E) rotavirus vaccine is effective and well-tolerated in Indian infants.