POTENCY TEST FOR JAPANESE ENCEPHALITIS VIRUS VACCINE, INACTIVATED, LYOPHILIZED

乙型脑炎病毒是急性脑炎的病原体。 中枢神经系统炎症性疾病 东亚。一种福尔马林灭活的小鼠脑衍生日本人 脑炎病毒疫苗已经生产出来。作为我们的一部分 监管功能我们已经开发了一项用于内部测试的协议 疫苗批量投放。最后一批集装箱疫苗在 四个稀释级别：1：5、1：25、1：125、1：625。六只四周大的雌性 每稀释一次疫苗就给小鼠接种一次疫苗。参考疫苗是 以相同的方式制备，每稀释一次免疫六只小鼠 参考资料。在第一次免疫后七天，小鼠 再次接种了疫苗。6只小鼠为未免疫小鼠，6只为 哨兵鼠，以排除老鼠病原体可能的干扰。 这六只小鼠的血清被提交进行抗体测试和 在研究结束时进行病理学检查。在学习的第15天 这些老鼠被放血以获取血清。每只老鼠的效价都是在 空斑减少中和抗体试验由疾控中心进行。我们 绘制疫苗和参照物的剂量反应曲线。这个 如果疫苗效力等于或大于等于，则通过疫苗抽签 参考文献的内容。

Japanese encephalitis virus is the causative agent of an acute inflammatory illness of the central nervous system found throughout eastern Asia. A formalin-inactivated, mouse-brain derived Japanese encephalitis virus vaccine has been manufactured. As part of our regulatory function we have developed a protocol for in house testing of vaccines for lot release. The final container vaccine lots are tested at four dilution levels: 1:5, 1:25, 1:125, 1:625. Six four-week old female mice are immunized per dilution of vaccine. The reference vaccine is prepared in the same manner and six mice are immunized per dilution of reference. Seven days after the first immunization the mice are immunized again. Six mice serve as unimmunized mice and six serve as sentinel mice to exclude possible interference by mouse-pathogenic agents. The sera of these six mice are submitted for antibody testing and pathology at the conclusion of the study. On the 15th day of the study the mice are bled for serum. The titer of each mouse is determined in a plaque reduction neutralizing antibody test to be performed by CDC. We develop a dose response curve for the vaccine and the reference. The vaccine lot passes if the potency of the vaccine is equal or greater than that of the reference.