Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: meeting at the crossroads.
Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: meeting at the crossroads.
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DOI：
10.1016/j.vaccine.2010.04.094
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发表时间：
2010-06-23
期刊：
影响因子：
5.5
通讯作者：
Lynn, Freyja
中科院分区：
文献类型：
--
作者：
Madore, Dace V.;Meade, Bruce D.;Rubin, Fran;Deal, Carolyn;Lynn, Freyja
2009年5月，国家过敏和传染病研究所主办了一个关于支持疫苗效力评估的血清学测定的讲习班。会议促进了从事抗感染剂疫苗研究的不同学科研究人员之间的思想交流，这些研究人员正处于不同的开发阶段。研讨会上的演讲和讨论说明了各种病原体面临的共同挑战，主题反复出现：1）全面了解病原体和宿主对疾病和免疫的反应是检测选择的基础。2)必须明确规定免疫测定数据的预期用途，以确保适当的特异性、准确性和精密度;实验室还必须投入资源以确保数据质量和可靠性。3)在疫苗开发过程中，免疫测定可能会在质量、目的和标准化程度方面发生变化，并且在某些情况下，随着数据的积累，必须进行更改或替换。4)在标准化试剂和方法、协调工作以及多学科团队方面的合作有助于一致地生成高质量数据。本报告根据从目前获得许可的疫苗中吸取的经验教训，为有效开发和利用免疫测定法提供了指导。鼓励研究者为科学交流创造更多机会，并指出所讨论的主题与用于其他目的（如治疗和诊断）的免疫测定相关。
In May 2009 the National Institute of Allergy and Infectious Diseases hosted a workshop on serologic assays that support vaccine efficacy evaluations. The meeting promoted exchange of ideas among investigators from varying disciplines who are working on anti-infectious agent vaccines at different stages of development. The presentations and discussions at the workshop illustrated the challenges common across various pathogens with recurring themes: 1) A thorough understanding of the science regarding the pathogen and the host response to disease and immunization is fundamental to assay selection. 2) The intended use of the immunoassay data must be clearly defined to ensure appropriate specificity, accuracy, and precision; a laboratory must also commit resources to assure data quality and reliability. 3) During vaccine development, an immunoassay may evolve with respect to quality, purpose, and degree of standardization, and, in some cases, must be changed or replaced as data are accumulated. 4) Collaboration on standardized reagents and methods, harmonization efforts, and multidisciplinary teams facilitates consistent generation of quality data. This report provides guidance for effective development and utilization of immunoassays based on the lessons learned from currently licensed vaccines. Investigators are encouraged to create additional opportunities for scientific exchange, noting that the discussed themes are relevant for immunoassays used for other purposes such as therapeutics and diagnostics.
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