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Plaque reduction neutralization test for measles antibodies: Description of a standardised laboratory method for use in immunogenicity studies of aerosol vaccination

机译:麻疹抗体的空斑减少中和试验:用于气溶胶疫苗免疫原性研究的标准化实验室方法的描述

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摘要

Background: Clinical trials of measles vaccination administered as aerosol are planned with the aim of obtaining licensure. Measles antibody levels will be measured using the plaque reduction neutralization test (PRNT) to assess antibody responses asa surrogate marker of efficacy. Methods: A working group examined laboratory protocols for measles PRNT in use at three reference centres and agreed to a standardised procedure, which was subsequently validated. Results: Assay validation showed quantitative results varied approximately threefold both within and between assays. The lower limit of detection was approximately 20 millilnternational Units/mL.
机译:背景:计划以气雾剂形式进行麻疹疫苗接种的临床试验,旨在获得许可。麻疹抗体水平将使用噬斑减少中和试验(PRNT)进行评估,以评估抗体反应作为疗效的替代指标。方法:一个工作组检查了三个参考中心使用的麻疹PRNT的实验室规程,并同意了标准化程序,随后对该程序进行了验证。结果:分析验证显示定量结果在分析内和分析之间变化了大约三倍。检测下限约为20毫升/毫升。

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