【摘要】 为观察多批次国产重组中国仓鼠卵巢细胞 (CHO细胞 )乙型肝炎 (乙肝 )疫苗的抗体反应和母婴传播阻断效果 ,1992～ 1999年应用 6批国产重组 (CHO细胞 )乙肝疫苗 ,按 0、1、6个月程序免疫 4 5 1名 6～ 12岁儿童。观察疫苗的安全性和接种后 1年内的抗体反应 ,并分别随访观察了 2～ 6年。同时应用 4批重组 (CHO细胞 )乙肝疫苗 ,免疫乙肝病毒表面抗原 (HBsAg)、乙肝病毒e抗原 (HBeAg)双阳性母亲的新生儿 12 2名 ,观察免疫后 1年内的母婴传播阻断保护效果。结果显示 :所有接种者未见严重副反应发生。完成全程免疫后 1个月 (T7)时 ,接种各疫苗组儿童的抗体阳转率均 >93% ,各组间差异无显著的统计学意义 (P >0 0 5 ) ,无或低应答率均值为 2 13% ,抗体滴度为2 11 74～ 347 2 7mIU/ml。 2～ 6年随访期间 ,不同疫苗组间抗体阳转率和抗体滴度有相同的下降趋势。 12 2名高危新生儿中 2 9人在免疫后 1年HBsAg持续阳性 ,母婴传播阻断保护率为 74 6 4 % (6 6 4 1%～ 85 19% )。表明国产重组 (CHO细胞 )乙肝疫苗安全性好 ,效果稳定 ,母婴传播阻断效果显著优于血源乙肝疫苗。更多还原

【Abstract】 This study carried out in 1992-1999 was to observe the antibody responses and prevention of mother-infant transmission of HBV by different lots of home-made recombinant Chinses hamster ovary (CHO) cell HB vaccine. We chose 451 children of 6-12 years old from four provinces of China, negative for HBsAg, anti-HBs and anti-HBc, vaccinated with 6 lots of recombinant CHO cell HB vaccine according to a 0, 1, 6 month schedule, and surveyed for vaccine safety and antibody responses after one year and followed up for 2-6 years. Another 122 healthy newborns born to HBsAg and HBeAg both positive mothers selected from three provinces were vaccinated with 4 lots of recombinant CHO cell HB vaccine, the preventive effect of HBV mother-infant transmission was observed within one year after vaccination. The results showed that all the vaccinees did not show any severe side effect 1 month after completion of whole-course vaccination, the anti-HBs positive seroconversion rates in children given different vaccine lots were all >93%, differences among 6 lots had no statistical significance (P>0.05). Non-responsive or low-responsive rate was 2.13% (mean value). The peak GMT titer of anti-HBs of 6 lots of the vaccine was at T7, 211.74mIU/ml～347.27mIU/ml. In the follow-up study, decreasing of positive rate and GMT titer of anti-HBs were observed in different vaccine lot immunized children. In 122 high-risk newborns, 29 were persistently HBsAg positive, the protective rate for HBV mother-infant transmission was 74.64% (66.41%～85.19%). The above results indicated that the home-made recombinant CHO cell HB vaccine is safe, stable, the mother-infant transmission interruption is much better than that of plasma-derived HB vaccine.更多还原