Abstract: Objective To use a standard stock for potency testing of HB vaccine in China.Metheods Two inbred strains(DBA/1 and BALB/c) and two NIH closes-colonies of mice were typed in the H-2 region by used microcytotoxicity method and PCR.Groups of mice of the tested strains were immunized with the same hepatitis B vaccine,the titre of anti-HBsAg antibody was analysed by microplate,the ED_(50) was then estimated bu Karder method for each strain.Results Significant differences were found between potency estimates derived from assays using different strains of mice.Conclusion It is likely that the variation of immune response to HB vaccine in mice is correlative with the H-2 haplotype.In some special case,the heterozygosity in H-2 region found in MIH stock could influence the accuracy in such testing even a reference preparation of HB vaccine was used.Base on our experiment,to select a appropriate NIH stocks with the H-2q haplotype for potency testing of HB vaccine in China.

Key words: HB vaccine, H-2, gene

摘要： 目的在进行乙肝疫苗效力检测时应用统一的动物种群。方法目前评价乙肝疫苗免疫效力的主要方法是用小鼠测定乙肝疫苗的ED50值(接种疫苗后使50%的动物抗体阳转的疫苗稀释度的倒数),而小鼠对HBsAg免疫应答的水平与H-2单倍型密切相关。因此我们通过微量细胞毒法和PCR方法检测小鼠的H-2单倍型的特点,得出乙肝疫苗与不同动物种群的相关性,解决实际工作中的问题。结果通过多方面的实验验证,NIH鼠可以对乙肝疫苗产生高应答效应。结论NIH鼠的H-2单倍型中有q型基因,同时NIH鼠保持了原封闭群动物繁殖力强生长速度快等优点,所以便于进行乙肝疫苗效力检测时应用。

关键词: 乙肝疫苗, H-2