STANDARDIZATION OF POTENCY TEST METHODS FOR IPV

不同方法检测小鼠血清免疫原性的评价 测定脊髓灰质炎病毒灭活疫苗效力的动物 基于D抗原的确定，已经在合作中进行 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不同结果(Wood DJ， Heath AB和Sawyer LA，Biologics 1995；23：83-94，Wood，D.J.和Heath， A.B.生物制品1995；23：301-311)指出有必要进一步 IPV效价体外测定方法的改进。工作是 在CBER改进的基础上发展了单抗ELISA法和 对替代的ELISA程序的评估，目标是 开发一种适合IPV效力测定的方法，即 CBER、制造商和其他监管机构均可接受。近期 结果进一步证明了评估的重要性。 灭活剂效价测定的试验结果 脊髓灰质炎病毒疫苗。 这项研究正在进行中，以开发一种更好的效力 IPV检测。目前用于测定效力的化验方法，如 根据制造商许可证的要求，测量血清学 猴子对接种三种剂量疫苗的反应。这个 今天可用的高效IPV疫苗很容易通过这种效力测试。 然而，猴子试验的局限性是，结果是 除了及格/不及格之外，很难量化。每一家IPV制造商也使用 某种形式的ELISA法程序，以遵循病毒的抗原性 生产过程中的疫苗。一种标准化的酶联免疫吸附试验程序的建立 这将改进疫苗的定量分析，并可能 用于准确的效力测定和消除猴子的使用 并提供更好的疫苗。IPV的效力测定将成为 随着美国转向更多地依赖IPV， 国家免疫规划。

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.