IN VIVO POTENCY OF INACTIVATED POLIOVIRUS VACCINE

国际上就衡量经济衰退的最佳方法达成了共识 脊髓灰质炎灭活病毒疫苗(IPV)在体外或体内的效力 还没有实现。实验室在最可行的方案上没有达成一致 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。在……里面 在美国和加拿大，猴子是需要进行IPV的地段 放手。每隔7天给猴子注射3次。这 过度免疫可能会模糊其抗原性。全新的纯净型 疫苗在猴子身上诱导一种抗体反应，这种抗体反应很少会失败 即使疫苗中的D-Ag单位水平较低，疫苗数量也很多 比建议的人体剂量要高。出于这些原因，我们正在 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 制造商分配的效价，三价的连续两倍稀释 制备成IPV。第一剂疫苗的效力是相同的。 相当于人类剂量。对6组小鼠进行了腹腔免疫。 只需注射一针。第21天检测中和抗体。 用酶联免疫吸附试验检测6种疫苗制剂的效力。 注射抗原量与中和的相关性 脊髓灰质炎1、2、3型的抗体应答分别为R=0.90、R=0.85、R=0.89 分别进行了分析。我们正在将这一方法扩展到 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 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.