IN VIVO POTENCY OF INACTIVATED POLIOVIRUS VACCINE

国际社会就衡量人口的最佳方法达成了共识， 灭活脊髓灰质炎病毒疫苗（IPV）在体外或体内的效力 尚未实现。 实验室不同意最可行的 效力的动物模型，因此实验室使用大鼠、豚鼠 猪、鸡或灵长类动物，由于许多原因，它们都不是理想的动物。 在 在美国和加拿大，猴子需要用于IPV批次 release. 每隔7天给猴子注射3次。 这 超免疫可能掩盖抗原性。 新净化 疫苗在猴子体内诱导抗体反应， 即使疫苗中D抗原单位水平较低， 比推荐的人体剂量还要多 由于这些原因，我们 寻找合适的动物模型。 我们有 选择Balb/c小鼠进行进一步研究。 基于 生产商指定效价，三价 制备了IPV。 第一剂疫苗的效力与 人体剂量。 腹腔免疫6组小鼠 一次注射。 在第21天测量中和抗体。 用ELISA法测定6种疫苗的效价。 抗原注射量与中和反应的相关性 脊髓灰质炎1型、2型和3型的抗体应答R=0.90，R= 0.85 R=0.89 分别 我们正在扩大这一做法， 确认其有效性。

An international consensus as to the best method for measuring the potency of inactivated poliovirus vaccines (IPV) in vitro or in vivo has not yet been achieved. Laboratories do not agree on the most feasible animal model of potency and therefore laboratories use rats, guinea pigs, chickens or primates none of which are ideal for many reasons. In the U.S. and Canada, the monkey is required for the purpose of IPV lot release. Monkeys are given 3 injections at 7 day intervals. This hyper-immunization may obscure the antigenicity. The new purified vaccines induce an antibody response in monkeys that would rarely fail a vaccine lot even if the level of D Ag units in the vaccine was lower than would be recommended for a human dose. For these reasons we are pursuing the identification of an appropriate animal model. We have selected the Balb/c mouse for further study. Based on the manufacturer's assigned potency, serial two-fold dilutions of trivalent IPV were prepared. The potency of the first vaccine dose was equivalent to a human dose. Six groups of mice were immunized intraperitoneally with one injection. Neutralizing antibodies were measured at 21 days. The potency of the six preparations of vaccine were measured by ELISA. The correlation between the amount of antigen injected and neutralizing antibody response was R=0.90, R= 0.85 R=0.89 for poliotypes 1, 2 and 3 respectively. We are in the process of expanding this approach to confirm its usefulness.