STUDIES OF IPV IN MICE TO REPLACE TEST IN MONKEYS

关于衡量效力的最佳方法的国际共识 体外或体内灭活脊髓灰质炎病毒疫苗(IPV)的研究尚未 已经实现了。实验室在最可行的动物模型上没有达成一致 因此实验室使用大鼠、豚鼠、鸡或 由于许多原因，灵长类动物中没有一种是理想的。在美国和加拿大， 猴子是IPV批次放行所必需的。猴子是 每隔7天注射3次。这种超级免疫可能会让人看不清 抗原性。新的纯化疫苗在体内诱导抗体反应 很少会有疫苗失败的猴子，即使D抗原单位的水平 在疫苗中的含量低于推荐的人体剂量。为 这些原因我们正在寻找一种合适的动物 模特。我们选择了Balb/c小鼠进行进一步的研究。基于 制造商分配的效力，三价IPV的连续两倍稀释 已经做好了准备。第一剂疫苗的效力相当于 人体剂量。对6组小鼠进行了一次免疫试验。 注射。第21天检测中和抗体。它的效力 用酶联免疫吸附试验对6种疫苗制剂进行检测。这种关联性 注射的抗原量和中和抗体反应之间的关系 1、2、3型脊髓灰质炎分别为R=0.90、R=0.85、R=0.89。我们是 在扩展这一方法的过程中，确认其有用性。

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 unit 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 was 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.