PROTECTION TEST FOR POTENCY OF INACTIVATED POLIOVIRUS VA

世卫组织最近未能接受IPV效力的国际标准测试。 目前在美国使用的测试并不理想：D抗原的ELISA测试并不总是准确地预测中和抗体反应，并且恒河猴的免疫原性测试需要敏感物种并且昂贵。 1997年，单价IPV免疫的TgPVR 21小鼠对野生型3型脊髓灰质炎病毒致死攻击的保护效力试验成功地扩展到其他两种类型的IPV。 证明了三种类型之间的抗原干扰，并且对由OPV疫苗株制备的IPV的免疫应答比对由野生型病毒制备的IPV的免疫应答差，并且结果已发表。 1998财政年度的进展受到阻碍，因为所有可获得的TgPVR 21小鼠都被用于世卫组织TgPVR小鼠合作研究，以测试口服脊髓灰质炎疫苗。 生产研究所已请求世卫组织和其他来源提供额外支持;如果小鼠可用，将使用它们完成本研究，比较标准D抗原ELISA试验和大鼠免疫原性试验与Tg小鼠攻毒保护试验，以估计IPV制剂的效价。 由于无法获得进行进一步研究所需的PVR Tg 21小鼠，该项目在1999财政年度处于非活动状态。但是，应保留项目编号和文件，以便进一步开发测试并将该方法应用于DVP中IPV的其他项目。

The WHO recently failed to accept an international standard test for the potency of IPV. The tests currently used in the USA are not ideal: ELISA tests of D Antigen do not always accurately predict neutralizing antibody responses, and tests of immunogenicity for rhesus monkeys require a sensitive species and are expensive. In FY 97, a potency test for protection of monovalent-IPV-immunized TgPVR21 mice against lethal challenge with wild-type type-3 poliovirus by was successfully extended to IPV of the other two types. Antigenic interference among the three types and a poorer immune response to IPV prepared from OPV vaccine strains than to IPV prepared from wild-type virus was demonstrated and results were published. Progress in FY 98 was impeded by the fact that all available TgPVR21 mice were used for the WHO Collaborative Study of TgPVR mice for testing OPV. The producing institute has requested additional support from the WHO and other sources; if mice become available, they will be used to complete this study, comparing a standard D-antigen ELISA test and a rat-immunogenicity test with the Tg-mouse challenge-protection test for estimating potency of IPV preparations. This project was inactive in FY 99 due to unavailability of PVR Tg21 mice needed to conduct further studies. However, the project number and file should be retained to allow further development of the test and application of the method to other projects on IPV in DVP.