WHO COLLABORATIVE STUDY OF INACTIVATED POLIOVIRUS VACCINE

目前，灭活脊髓灰质炎病毒疫苗（IPV）效力的检测需要 实验室之间的标准化。 一项合作研究已经 开始评估候选参考物质的适用性。 这项研究的另一个方面是评估候选人的合适性 通过ELISA进行D抗原测定的标准方法，并评估 个人使用的IPV效价估计方法的熟练程度 laboratories. 本研究中包括的材料是两种商业上的 制备的候选参比物质;主要参比物质PU 78 -02 目前有几个实验室使用，不同的疫苗 生产商证明在人体中具有免疫原性;由Sabin生产的IPV 菌株和疫苗的体内效力差。 研究将分为 分为两个阶段。 目前正在进行的第一阶段将涉及 体外测定和第二阶段体内测定。 在CBER开发的ELISA使用单克隆抗体作为检测抗体 D抗原特异性抗体是候选标准方法。 我们 灌装和冻干我们的内部试剂，以分发给 合作者 进行了几项测试以验证冻干的 在邮寄之前， 我们准备了详细的SOP，其中包括 实践抗原和测试抗原的稀释方案。 的 合作者已经收到了一个ELISA试剂盒，包含板，多克隆 三种脊髓灰质炎病毒的单克隆抗体和单型抗原 用于实践的类型以及SOP和我们的测试结果 使用单型抗原。 将标记为A-F的测试抗原邮寄给 在稍后的日期。 测试正在进行中。 我们目前正在评估 Balb/c小鼠作为体内效力的模型作为单独的研究。 我们 计划提出使用Balb/c小鼠作为体内候选标准 第二阶段合作研究的效力方法。 我们将 参与研究各阶段的分析和报告。

The current tests for inactivated poliovirus vaccine (IPV) potency need standardization between laboratories. A collaborative study has been initiated to assess the suitability of candidate reference materials. Another aspect of the study is to assess the suitability of a candidate standard method for D antigen assay by ELISA, and to assess the proficiency of methods for potency estimation of IPV used by individual laboratories. The materials included in this study are two commercially prepared candidate reference materials; the primary reference PU78-02 currently used by several laboratories, vaccines from different manufacturers shown to be immunogenic in humans; IPV produced from Sabin strains and vaccines of poor in vivo potency. The study will be divided into two phases. The first phase which is in progress will involve in vitro assays and the second phase in vivo assays. An ELISA developed at CBER using as detection antibodies monoclonal antibodies specific for D antigen is the candidate standard method. We filled and lyophilized our in-house reagents for distribution to collaborators. Several tests were performed to validate the lyophilized reagents prior to mailing. We prepared a detailed SOP which included the dilution schemes for both practice antigens and test antigens. The collaborators have received an ELISA kit containing plates, polyclonal and monoclonal antibodies and monotypic antigen of all three poliovirus types for practice together with the SOPs and the results of our tests using the monotypic antigens. The test antigens labeled A-F were mailed at a later date. Testing is in progress. We are currently evaluating the Balb/c mouse as a model of in vivo potency as a separate study. We plan to propose using Balb/c mice as a candidate standard in vivo potency method for the second phase of the collaborative study. We will be involved in the analysis and reporting of the study at each phase.