Twenty years of outpatient respiratory syncytial virus infection: A framework for vaccine efficacy trials
Twenty years of outpatient respiratory syncytial virus infection: A framework for vaccine efficacy trials
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DOI：
10.1542/peds.99.2.e7
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发表时间：
1997-02-01
期刊：
影响因子：
8
通讯作者：
Wright, PF
中科院分区：
文献类型：
--
作者：
Fisher, RG;Gruber, WC;Wright, PF
背景呼吸道合胞病毒（Respiratory syncytial virus，RSV）是婴幼儿呼吸道最重要的病毒性病原体。关于重症住院病人的情况已经写了很多。然而，住院病人只占感染RSV儿童的少数。我们研究了健康儿童中有症状的门诊RSV感染的特征，以更好地了解RSV疾病，并为无高危状况儿童的干预策略测试提供背景。在连续20个RSV季节期间，共对1113名儿童进行了随访。监测呼吸道感染的体征和症状。获得发热性上呼吸道感染、急性中耳炎和下呼吸道感染（LRI）的培养物。计算发热性上呼吸道感染、急性中耳炎、LRI和住院率。根据这些比率，计算了证明疫苗产品有效性所需的儿童人数。RSV感染引起的轻度疾病缺乏住院儿童RSV感染的一些典型特征。然而，RSV感染的下呼吸道受累率远高于其他病毒性呼吸道病原体感染。因此，LRI被认为是疫苗试验的最佳候选终点。一个产品有60%的疗效可以被证明，功效为0.8，是有效的，只有1500名婴儿。RSV感染是常见的，通常涉及下呼吸道，即使在门诊患者中也是如此。我们对RSV感染的20年研究为计算候选疫苗试验中使用的样本量提供了基础。
Background. Respiratory syncytial virus (RSV) is the most important viral respiratory pathogen of infancy and childhood. Much has been written about inpatients with severe disease. Inpatients, however, represent only a minority of RSV-infected children. We studied the characteristics of symptomatic outpatient RSV infection in healthy children to gain a better understanding of RSV disease and to provide a background for the testing of intervention strategies in children without high-risk conditions.Methods. A total of 1113 children were followed during 20 consecutive RSV seasons. Signs and symptoms of respiratory infection were monitored. Cultures were obtained for febrile upper respiratory infection, acute otitis media, and lower respiratory infection (LRI). Rates of febrile upper respiratory infection, acute otitis media, LRI, and hospitalization were calculated. Given those rates, numbers of children needed to demonstrate efficacy of a vaccine product were calculated.Results. Mild disease from RSV infection lacked some of the classic features of RSV infection seen in hospitalized children. Involvement of the lower respiratory tract was, however, noted to be much higher in RSV infection than it was in infection with other viral respiratory pathogens. LRI was, therefore, considered the best candidate endpoint for vaccine trials. A product with 60% efficacy could be proven, with a power of 0.8, to be efficacious with as few as 1500 infants.Conclusions. RSV infection is common and often involves the lower respiratory tract, even in outpatients. Our 20-year study of RSV infection provides a basis for calculation of sample sizes to be used in trials of vaccine candidates.