甲型肝炎灭活疫苗有效剂量的评价

Evaluation of efficacy dose on inactivated HAV vaccine

目的 评价佐剂吸附甲型肝炎成品疫苗有效免疫剂量。方法 将 4个厂家的 4批甲型肝炎灭活疫苗进行解离吸附后 ,检测比较HAV抗原含量 ;通过小白鼠体内效力实验 ,计算半数有效稀释倍数 ,比较评价各组疫苗的免疫效力。结果 体外吸附解离HAV抗原含量与体内免疫效力相偏离 ,传统概念上的半数有效剂量 (ED50 )不能用作比较评价指标。结论 体内半数有效稀释倍数可用于甲型肝炎灭活疫苗有效剂量的评价。

Objective To evaluate the immune dose of Aluminium adjuvant absorbed inactivated HAV vaccines.Methods Firstly,after desorption of 4 lots of inactivated HAV vaccines made from 4 pharmaceutical factories respectively,HAV antigen content was detected by ELISA; Then potency test was performed in mice in vivo ,and the mean efficacy dilution was calculated to evaluate the immunogenicity of different vaccines.Results The content of HAV antigen desorpted from the final products deviated apparently from the immunogenicity efficacy,the mean effective dose(ED50)can't be used as the parameter for evaluation these vaccines' immunogenicity.Conclusion The mean efficacy dilution can be used as the parameter to evaluate the immune dose on inactivated HAV vaccines.