New approaches to the assessment of vaccine herd protection in clinical trials
New approaches to the assessment of vaccine herd protection in clinical trials
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DOI：
10.1016/s1473-3099(10)70318-2
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发表时间：
2011-06-01
影响因子：
56.3
通讯作者：
Ali, Mohammad
中科院分区：
文献类型：
--
作者：
Clemens, John;Shin, Sunheang;Ali, Mohammad
将新疫苗引入常规公共卫生实践的标准正变得越来越严格。对于昂贵的疫苗和提供适度保护的疫苗，提供群体保护的能力可能对疫苗引进的政策审议至关重要。传统上，在引入疫苗后评估牛群保护，延迟了关于牛群效应的数据的可用性，以告知有关疫苗引入的决定。新的方法学发展现在提供了在将疫苗引入公共卫生规划之前评估畜群保护的可能性。一种方法是群集随机试验，它允许以最小化偏差的方式评估羊群保护。通过适当选择的事后创建的集群对单独随机试验进行分析也可以提供群体保护的测量。在这里，我们将讨论这些设计的使用，这些设计可以在早期阶段产生一个改进的证据基础，以便做出关于引入新疫苗的决策。
Criteria for the introduction of new vaccines into routine public health practice are becoming increasingly stringent. For vaccines that are expensive and those that provide moderate protection, the ability to confer herd protection could be crucial to policy deliberations about vaccine introduction. Traditionally, herd protection has been assessed after a vaccine is introduced, delaying the availability of data on herd effects to inform decisions about vaccine introduction. New methodological developments now provide the possibility to assess herd protection before the introduction of a vaccine into public health programmes. One approach is a cluster-randomised trial, which allows assessment of herd protection in a way that minimises biases. Analysis of individually randomised trials by appropriately selected clusters created post hoc can also provide measurements of herd protection. Here we discuss the use of these designs, which can generate an improved evidence base at an early stage for making decisions about the introduction of new vaccines.