Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial
Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial
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DOI：
10.1016/s0140-6736(98)12106-2
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发表时间：
1999-07-24
期刊：
影响因子：
168.9
通讯作者：
Ward, RL
中科院分区：
文献类型：
--
作者：
Bernstein, DI;Sack, DA;Ward, RL
轮状病毒是世界范围内婴儿严重脱水性腹泻的最常见原因。我们在一项随机、安慰剂对照、双盲、多中心试验中评估了口服人轮状病毒活疫苗89-12在美国儿童中的安全性、免疫原性和有效性。方法215名健康婴儿入选，其中213名接受两剂89-12（含1x 10（5）空斑形成单位）或安慰剂，213名随访一个轮状病毒季节。在每次接种疫苗后7天内比较副作用的频率。通过血清和粪便伊加以及血清89-12中和滴度评估对轮状病毒的免疫应答。主要结果变量（保护轮状病毒疾病）进行了评估，通过比较轮状病毒胃肠炎的频率在意向治疗analysis.Findings不良反应轻微。第一次接种后的低烧（大于或等于38.1摄氏度）是疫苗组比安慰剂组更常见的唯一副作用（21 [19%] vs 5 [5%]，p=0.001）。在94.4%的接种者中检测到对疫苗的免疫应答。107例安慰剂接种者中有18例发生轮状病毒病，108例疫苗接种者中有2例发生轮状病毒病（疫苗有效性89.0% [95%CI 65.4-94.5]）。安慰剂组中有10名婴儿，但疫苗组中没有一名婴儿接受医疗护理。解释89-12轮状病毒疫苗是安全的和免疫原性的，对轮状病毒疾病提供了高度的保护。需要对该疫苗进行进一步研究，以在其他环境中证实这些发现。
Background Rotavirus is the most common cause of severe, dehydrating diarrhoea in infants worldwide. We assessed the safety, immunogenicity, and efficacy of a live, oral human rotavirus vaccine, 89-12, in US children in a randomised, placebo-controlled, double-blind multicentre trial.Methods 215 healthy infants were enrolled, of whom 213 were given two doses of 89-12 (containing 1x10(5) plaque-forming units) or placebo, and 213 were followed up through one rotavirus season. The frequency of side-effects was compared for 7 days after each dose of vaccine. Immune responses to rotavirus were assessed by serum and stool IgA, and by serum 89-12 neutralising titres. The primary outcome variable (protection from rotavirus disease) was evaluated by comparing the frequencies of rotavirus gastroenteritis in an intention-to-treat analysis.Findings Adverse reactions were mild. Low-grade fever (greater than or equal to 38.1 degrees C) after the first dose was the only side-effect significantly more common in the vaccine group than in the placebo group (21 [19%] vs 5 [5%], p=0.001). An immune response to vaccine was detected in 94.4% of vaccinees. Rotavirus disease occurred in 18 of 107 placebo recipients and two of 108 vaccine recipients (vaccine efficacy 89.0% [95% CI 65.4-94.5]). Ten infants in the placebo group but none in the vaccine group were presented for medical care.Interpretation The 89-12 rotavirus vaccine was safe and immunogenic and provided a high degree of protection against rotavirus disease. Further investigations of this vaccine are needed to confirm these findings in other settings.