肠道病毒71型灭活疫苗体外和体内相对效力试验的相关性

Correlation of relative potency tests in vitro and in vivo of inactivated enterovirus 71 vaccine

目的评价肠道病毒71型(enterovirus type 71,EV71)灭活疫苗体外和体内相对效力试验检测结果的相关性。方法以EV71灭活疫苗上市以后1个自然年内生产的62批EV71灭活疫苗为研究对象,进行体外(抗原含量测定)和体内相对效力试验(ED50效力试验和中和抗体效价检测),并分析62批EV71灭活疫苗的抗原含量与半效稀释倍数、ED50效力、中和抗体效价的相关性及ED50效力与中和抗体效价的相关性。结果抗原含量与半效稀释倍数及中和抗体效价呈良好正相关(P<0.01),ED50效力与中和抗体效价呈显著负相关(P<0.01),抗原含量与ED50效力无相关性(P>0.05)。结论体外相对效力试验替代体内相对效力试验用于EV71灭活疫苗效力检测具有可行性。

Objective To evaluate the correlation of relative potency test results in vitro and in vivo of inactivated enterovirus 71(EV71)vaccine.Methods Sixty-two batches of inactivated EV71 vaccine produced in a calendar year were subjected to relative potency tests in vitro(determination of antigen content)and in vivo(determination of ED50 potency and neutralizing antibody titer),based on which the correlation of antigen content to median effective dilution factor,ED50 potency and neutralizing antibody titer as well as the correlation of ED50 to neutralizing antibody titer were analyzed.Results The antigen content showed significantly positive correlation with the median effective dilution factor and neutralizing antibody titer(P<0.01),while the ED50 showed significantly negative correlation with neutralizing antibody titer(P<0.01).However,there was no correlation between antigen content and ED50 potency.Conclusion It is feasible to determine the potency of inactivated EV71 vaccine by relative potency test in vitro instead of the potency test in vivo.