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对国产痘苗病毒乙肝基因工程疫苗(北京生物制品研究所研制)和地鼠卵巢细胞乙肝基因工程疫苗(长春生物制品研究所研制)进行阻断乙肝母婴传播的效果观察,剂量为20μg/支×3,接种HBsAg和HBeAg均阳性母亲的新生儿各40例,观察时间≥9个月者分别为33例和29例。结果:全部新生儿均无局部或全身不良反应,T1时抗-HBs阳转率分别为3.0%和13.8%;T9时达高峰,分别为78.8%和79.3%;疫苗保护率分别为79.2%和80.2%;抗-HBs滴度(S/N均值)T9时为高峰,分别为113.04和99.11。各组中均有1例抗-HBs和HBsAg同时持续阳性;并分别有1例和2例抗-HBs均持续阴性。结果表明国产乙肝基因工程疫苗均有良好的安全性和免疫原性,其阻断乙肝母婴传播的效果较同剂量血源疫苗好,与30μg血源疫苗的阻断效果相近。
The effect of blocking the mother-to-child transmission of hepatitis B was observed in domestic vaccinia virus hepatitis B genetically engineered vaccine (Beijing Institute of Biological Products) and hamster ovary cell hepatitis B gene engineering vaccine (Changchun Institute of Biological Products) at a dose of 20 μg / 40 newborns vaccinated with HBsAg and HBeAg positive mothers each had 40 cases and the observation time was 9 months and 33 cases and 29 cases respectively. Results: All newborns had no local or systemic side effects. The positive rate of anti-HBs was 3.0% and 13.8% at T1, and reached 78.8% and 79.3% respectively at T9. The vaccine protection rates were 79.2% and 80.2%, respectively. The titer of anti-HBs (S / N mean) peaked at T9, which were 113.04 and 99.11, respectively. In both groups, 1 case of anti-HBs and HBsAg sustained positive at the same time, and 1 case and 2 cases of anti-HBs were negative. The results showed that domestic hepatitis B genetically engineered vaccine has good safety and immunogenicity, the effect of blocking the mother-to-child transmission of hepatitis B than the same dose of blood-borne vaccine is good, and 30-g blood vaccine similar blocking effect.