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本文报告以NIH乙肝灭活疫苗及PBS为对照,用随机双盲法对新生儿在0、1、6月龄时分别皮下注射1剂,试图阻断HBV母——婴传播,观察12个月。结果HBsAg和HBeAg均阳性母亲的10名新生儿中,接种疫苗的7名有6名(85.71％)产生抗-HBs应答,仅1名免疫失败。而注射PBS的3名新生儿HBsAg均持续阳性。母亲无HBV感染标记的5名新生儿中,3名接受疫苗的均产生抗-HBs应答;注射PBS的2名则未检出HBV感染标记。接受免疫的二组新生儿均无明显不良反应,表明乙肝疫苗阻断HBV母——婴传播安全有效。
This report reports NIH hepatitis B inactivated vaccine and PBS as a control, a randomized double-blind method of newborns at 0,1,6 months of age were injected subcutaneously one dose in an attempt to block HBV mother-infant transmission observed 12 months . Results Of the 10 newborns with HBsAg and HBeAg-positive mothers, 6 out of 7 (85.71%) vaccinated patients developed anti-HBs responses and only 1 immunocompromised. HBsAg was consistently positive in 3 newborns injected with PBS. Of the 5 newborns whose mothers had no HBV infection, 3 received anti-HBs responses to the vaccine and 2 did not receive the HBV infection. Immunized groups of two newborns were no obvious adverse reactions, indicating that hepatitis B vaccine block HBV mother - infant transmission is safe and effective.