PROTECTION TEST FOR POTENCY OF INACTIVATED POLIOVIRUS VA

灭活脊髓灰质炎病毒 VA 效力的保护测试

• 批准号: 6101340
• 负责人: ROLF E TAFFS
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6101340
• 关键词: biological models; genetic strain; genetically modified animals; human genetic material tag; laboratory mouse; neurotropic virus; neutralizing antibody; passive immunization; poliomyelitis vaccine; poliovirus; virulence; virus antigen; virus receptors

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.

世界卫生组织最近未能接受国际标准的IPV效力测试。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，而且恒河猴的免疫原性测试需要敏感的物种，而且价格昂贵。在97财年，一项保护单价IPV免疫的TgPVR21小鼠免受野生型3型脊髓灰质炎病毒致死攻击的效力试验被成功地推广到其他两种类型的IPV。这三种病毒之间存在抗原干扰，OPV疫苗株对IPV的免疫应答弱于野生型IPV，并发表了研究结果。所有可用的TgPVR21小鼠都被用于世卫组织TgPVR小鼠检测OPV的合作研究，这阻碍了98财年的进展。生产研究所已经要求世界卫生组织和其他来源提供额外的支持；如果有小鼠可用，将使用它们来完成这项研究，将标准D抗原ELISA测试和老鼠免疫原性测试与TG小鼠挑战保护测试进行比较，以评估IPV制剂的效力。由于PVR Tg21小鼠无法使用，该项目在1999财年处于停滞状态，需要进行进一步的研究。但是，应保留项目编号和文件，以便进一步开展该方法的测试，并将其应用于DVP中关于IPV的其他项目。