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1992年我国研究开发成功甲型肝炎 (甲肝 )减毒活疫苗 (H2 株 )。十几年中建立了普通狨猴动物模型 ;将细胞-病毒培养系统的生产工艺做了重大改进 ;对 1989～ 1997年生产的 16批疫苗做了现场人体观察 ,未见不良反应及血清丙氨酸氨基转移酶 (ALT)升高 ,接种后抗体阳转率为 81 8%～ 10 0 0 % ,几何平均滴度 (GMT)为 1∶2 1～ 1∶5 0。K7疫苗病毒为IB基因亚型 ,经体内外多次传代或从接种者排出的病毒做序列分析 ,其与K7株的同源性达99 3%～ 10 0 0 % ,显示减毒性质、遗传稳定性不变。易感者接种疫苗后粪便排毒率为 85 7%～ 90 3% ,接触者为6 3 6 %～ 71 9% ,说明活疫苗接种后有次传播能力 ,但毒株均显弱毒性质 ,无毒力返祖现象。结果表明 :H2 株甲肝减毒活疫苗的安全性、免疫原性良好 ,应该继续推广使用
In 1992, China successfully developed a Hepatitis A (H) attenuated live vaccine (H2 strain). Ten years in the establishment of a common animal model of macaque; cell-virus culture system has made significant improvements in the production process; 1989-1997 production of 16 batches of vaccines on-site human observation, no adverse reactions and serum ammonia Acid aminotransferase (ALT) increased after inoculation antibody positive rate of 81 8% ~ 100%, geometric mean titer (GMT) of 1: 21 ~ 1: 50. The K7 vaccine virus is a subtype of IB genotype, sequenced by multiple passages in vitro and in vivo or from the virus of vaccinates, and its homology with K7 strain is 99 3% -100%, indicating the attenuated nature and genetic Stability unchanged. The rate of excretion of excrement after susceptible vaccination was 85.7% ~ 90.3% and the contact rate was 63.6% ~ 71.9%, which indicated that the live vaccine had the secondary transmitting ability after inoculation, but all the strains showed weak poisonous nature and non-toxic Force back to ancestral phenomenon. The results showed that the live attenuated HAV vaccine was safe and immunogenic and should be further popularized