CHO细胞重组乙型肝炎疫苗的免疫原性及保存稳定性的研究  

STUDY ON IMMUNOGENICITY AND CONSERVATION STABILITY OF RECOMBINANT CHO CELLS DERIVED HEPATIS B VIRUS VACCINE

作　　者：周平华[1] 吕东升[1] 孙亨凡 朱德芳[1] 罗红[1] 方志正[1] 

机构地区：[1]武汉生物制品研究所,430060

出　　处：《微生物学杂志》1999年第3期7-8,共2页Journal of Microbiology

摘　　要：将9批CHOC28细胞重组乙肝疫苗（简称CHO苗）与同期生产的48批血源性化学灭活疫苗（简称血源苗），检定所CHO参比苗、血源参比苗、酵母重组苗和巴士德CHO苗按10μg／ml同等剂量进行免疫原性的比较。产生小民免疫后50％阳转的最小抗原至平均值分别是0.10μg、0．17μg、0．18μg、0．35μg、0.79μg和0．18μg，CHO苗与血源苗的免疫原性水平均较高，但前者优势明显，而酵母重组苗的EDO结果最差。武汉所CHO苗在4～8℃保存2年后ED50均值仍是0．14μg，有效抗原性基本不变，CHO参比苗2年后ED50为0．35μg，仍具有高效免疫活性；血源参比苗稳定性效果一年半的ED5O为1.20；稳定性最差的是该批酵母重组苗，在1年内ED50位降至稀释度4以下（大于2．5μg）。上述结果表明CHO细胞重组苗在长期保存稳定性方面质量可靠，同类苗中武汉所疫苗占一定的优势。Nine batches of CHO C28 vaccine were studied by comparing with 48 batches of plasma derived vaccine, yeast derived recombinant vaccine, Pasteur CHO cells derived vaccine produced in the corresponding peried in the same dose of 10μg/dose for the efficacy of their immunogenicity. Two kinds of naional vaccine (930101&937) were also used as control. The minimum antigen which causes 50% of mice positive conversion is 0. 10μg, 0. 17μg, 0.18μg, 0. 35μg, 0.79μg and 0. 18μg respectively. The immunogenicity of CHO derived and plasma derived vaccine were high above the two controls’. However, the superior of CHO vaccine is obviously, the efficiency of yeast derived vaccine is discontented. The long-term stability of this CHO vaccine also shows an encouraging persistence of its immunogenicity after two years cool conservation. And its EDO is 0. 14μg, while its controller is 0. 35μg. Three plasma derived vaccines after two years' conservaion are also sampled. The results were 0. 83μg, 0. 73μg, and 1. 2μg respectively, better than its controls which conserved for 18 months. Yeast derived vaccine dropped its ED50 to 2. 5μg in one year and turned invalid. These results demonstrated the superiority of conservation stability of Wuhan Institute products over the same kinds of vaccine.

关 键 词：乙肝疫苗 CHO细胞 重组疫苗 免疫原性 稳定性 

分 类 号：R512.620.3[医药卫生—内科学]