乙肝基因工程疫苗阻断HBV母婴传播的效果观察

Interruption of Perinatal Transmission ofHBV by Chinese Recombinant Hepatitis BVaccine

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。

ixty-two infants who were born fromHBsAg and HBeAg both positive mothers werevaccinated with 20μg/dose recombinatn hepatitisB vaccine,which was made in Beijing Instituteof Biologic Products(Vaccinia Virus recombinanthepatitis B vaccine)and changchun Instituteof Biologic Products(Chinese bamster ovary cells recombinant hepatitis B vaccine),at 0,1,6 months. All the babies were followed up for9 or 12 months. The results showed that the protective rates of Beijing vaccine and Chang-chun vaccine were 79.2% and 80.2%,respectively,the positive rates of anti-HBs were 78.8%and79.3%,respectively. Local or systemaic reactions were not found in all the babies 3 days after injection. These results suggested that the Chinese recombinant hepatitis B vaccine was safe and effective. It was better than the plasma vaccine with the same dose.