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Statistical considerations for vaccine immunogenicity trials Part 1: introduction and bioassay design and analysis

机译：疫苗免疫原性试验的统计注意事项第1部分：简介和生物测定设计与分析

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The foundation for any vaccine immunogenicity trial is the identification of appropriate correlates for protection and the measurement of these quantities with well-designed bioassays. An important requirement for developing bioassay protocols is the standardization of each procedure, so it is performed in a uniform manner within a facility and, in the case of multicenter trials, across laboratories. It is also crucial to recognize that the selection and use of techniques used to quantify assay endpoints (e.g., antibody concentration) will affect their accuracy and precision and these methods must also be defined and uniformly applied within and across laboratories. This paper discusses a number of methodological issues related to bioassay design and analysis that would ultimately lead to highly accurate assay endpoint determinations with minimum variance that would be comparable across laboratories. Guidelines are presented for the development of bioassay and data analysis protocols. Strengthening vaccine immunogenicity trial protocols will ensure that these quantities are estimated with the greatest degree of reliability and facilitate the subsequent evaluation of new vaccine formulations. Following these guidelines will give other researchers as well as regulatory authorities more confidence in evaluating and comparing the differences in immunogenicity levels elicited by new and developing vaccines.
机译：任何疫苗免疫原性试验的基础都是确定适当的相关保护因子，并通过精心设计的生物测定法对这些数量进行测量。开发生物测定规程的一个重要要求是每个程序的标准化，因此它必须在工厂内以统一的方式进行，对于多中心试验，则需要跨实验室进行。同样重要的是要认识到，用于量化测定终点（例如抗体浓度）的技术的选择和使用将影响其准确性和精确度，并且这些方法也必须定义并在实验室内部和实验室之间统一应用。本文讨论了与生物测定设计和分析有关的许多方法学问题，这些问题最终将导致高度准确的测定终点确定，而最小方差在各个实验室之间是可比的。提出了生物测定和数据分析方案开发的指南。加强疫苗免疫原性试验方案将确保以最大程度的可靠性估算这些数量，并有助于后续评估新疫苗制剂。遵循这些准则将使其他研究人员和监管机构在评估和比较新疫苗和开发中疫苗引起的免疫原性水平上的差异时更有信心。

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