STANDARDIZATION OF POTENCY TEST METHODS FOR IPV

评价替代ELISA方法和免疫原性试验， 脊髓灰质炎病毒灭活疫苗（IPV）效力测定用动物 基于D抗原测定， 与世卫组织、疫苗制造商和其他国家控制当局合作。 在这些合作研究中获得的可变结果（Wood DJ， Heath AB和索耶LA，生物制品1995;23：83-94，Wood，D. J. A.B. Biologicals 1995;23：301-311）表明需要进一步的研究。 IPV效力的体外测定的改进。 工作是 继续改进CBER开发的单克隆ELISA， 替代ELISA程序的评价，目的是 开发用于IPV效价测定的合适方法， CBER、制造商和其他监管机构可接受。最近 结果进一步证明了评价的重要性， 测定灭活疫苗效价的试验结果 脊髓灰质炎病毒疫苗。 这项研究正在进行，以开发一种改进的效力， 测定IPV。 目前用于测定效价的试验，如 根据制造商许可证的要求，测量血清学 猴子对接种三剂疫苗的反应。 的 目前可获得的高效力IPV疫苗容易通过该效力测定。 然而，猴子测试的局限性在于， 除了通过/未通过之外难以定量。 IPV的每个制造商也使用 一些形式的ELISA程序，以遵循的抗原特性， 疫苗生产过程中 标准化ELISA程序的开发 这将改善疫苗的定量分析， 用于准确的效价测定，并消除使用猴子 并提供更好的疫苗 IPV的效价测定将成为 随着美国转向越来越依赖IPV， 国家免疫计划。

Evaluation of alternative ELISA methods and immunogenicity tests in small animals for determining potency of Poliovirus Vaccine Inactivated (IPV) based on D antigen determinations, has been conducted in collaboration with WHO, vaccine manufacturers, and other national control authorities. The variable results obtained in these collaborative studies (Wood DJ, Heath AB, and Sawyer LA, Biologicals 1995;23:83-94,Wood,D.J. and Heath, A.B. Biologicals 1995;23:301-311) indicated the need for further improvements in in vitro determinations of IPV potency. Work is continuing of the improvement of the CBER developed monoclonal ELISA and the evaluation of alternative ELISA procedures, with the goal of developing a suitable method for IPV potency determinations that is acceptable to CBER, manufacturers, and other regulatory agencies. Recent results have provided further evidence of the importance of evaluation of test results in the determination of the potency of inactivated poliovirus vaccines. This research is being pursued in order to develop an improved potency assay for IPV. The assay currently used to determine potency, as required by the manufacturer's license, measures the serological response of monkeys to inoculation with three doses of the vaccine. The high potency IPV vaccines available today easily pass this potency assay. However, the monkey test suffers from the limitation that the results are hard to quantitate beyond pass/fail. Every manufacturer of IPV also uses some form of ELISA procedure to follow the antigenic properties of the vaccine during manufacture. Development of a standardized ELISA procedure that would improve the quantitative analysis of the vaccine and could be used for accurate potency determinations and eliminate the use of monkeys and provide a better vaccine. Potency determinations of IPV will become of increased importance as the US switches to increased reliance on IPV in the national immunization program.