李洪哲;郑惠文;杨晓蕾;陈梦娇;邓燕;许秀雯;朱云;戴永娟;王海;孙明波;杨净思;

• 1:中国医学科学院北京协和医学院医学生物学研究所生物制品四室

摘要(Abstract)：

目的评价不同剂量配比及制备工艺的吸附无细胞百日咳-白喉-破伤风-乙型肝炎-Sabin株灭活脊髓灰质炎联合疫苗(DTa P-Hep B-s IPV)的基础免疫效果。方法以中、低剂量s IPV与铝佐剂相互配伍的不同配方,设计4个DTa P-Hep B-s IPV联合疫苗实验组,即中剂量含铝佐剂s IPV组(A组)、中剂量不含铝佐剂s IPV组(B组)、低剂量含铝佐剂s IPV组(C组)、低剂量不含铝佐剂s IPV组(D组),并设相应各组分的对照组和上市的联合疫苗参考组。按0、1、2月基础免疫程序,经左右腿肌肉接种Wistar大鼠,于免前及每剂免后第30天釆血,检测各组大鼠血清中各组分抗体水平、GMT及阳转率。结果大鼠经全程基础免疫后,A、B组各型别脊灰病毒中和抗体阳转率均达到100%,C、D组为80%~100%;A、C组各剂次免后所诱导的各型别脊灰病毒中和抗体GMT值均高于同等剂量不含铝佐剂的B、D组,且均达到或超过参考组;B、D组所诱导的各型别脊灰病毒中和抗体GMT值均低于同等剂量的对照组。各组百白破抗体阳转率在首剂免后均达到100%,每剂免后,实验组百白破抗体GMT与对照组相比,差异均无统计学意义(P均>0.05)。基础免疫完成后,实验组和参考组乙型肝炎表面抗体阳转率为40%~88.9%;各实验组乙型肝炎抗体水平与对照组、参考组相比,差异均无统计学意义(P均>0.05)。结论 s IPV中剂量含铝佐剂的DTa P-Hep Bs IPV联合疫苗可诱导大鼠在基础免疫过程中产生良好且稳定的体液免疫反应。

关键词(KeyWords)： 吸附无细胞百日咳疫苗;白喉;破伤风;乙型肝炎;脊髓灰质炎;联合疫苗;免疫原性

Abstract:

Keywords:

基金项目(Foundation): 国家十二五“重大新药创制”科技重大专项(2015ZX09101-031)

作者(Author): 李洪哲;郑惠文;杨晓蕾;陈梦娇;邓燕;许秀雯;朱云;戴永娟;王海;孙明波;杨净思;

Email:

DOI: 10.13200/j.cnki.cjb.001313

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