低抗原含量百日咳疫苗效力评价研究

摘要

目的 应用改良小鼠脑腔攻击试验(MICA)检测评价低抗原含量百日咳疫苗效力.方法 通过中检院和国外实验室平行应用改良小鼠脑腔攻击试验进行不同稀释度相同批次低抗原含量百日咳疫苗的效力,并应用统计软件分析.结果 中检院与国外实验室所获得低抗原含量百日咳疫苗的MICA试验效力结果数据均较低(<1.1 IU/mL),中检院计算出的效价均在国外实验室分析得出效价的95%可信区间内.结论 MICA方法可应用于低抗原含量百日咳疫苗效力检测分析,该研究为进一步确定中国低抗原含量百日咳疫苗的MICA试验检定标准奠定了基础.%Objective To evaluate the potency of low -antigen-content of pertussis vaccine by modified intracerebral challenge po -tency .Methods The same lots of pertussis vaccines at different dilutions were detected in parallel using the MICA in NIFDC,China and foreign laboratory .All the data were analyzed using statistical software .Results The results from NIFDC and foreign laboratory showed that the MICA potency units of low-antigen-content pertussis vaccine detected was low (