【摘要】 目前国产酵母重组乙型肝炎 (乙肝 )疫苗已取代血源性乙肝疫苗 ,为了解国产酵母重组乙肝疫苗现场应用的免疫效果和阻断乙肝母婴传播的效果而进行了观察研究。应用深圳康泰生物制品有限公司生产的酵母重组乙肝疫苗 ,采用 0、1、6和 0、1、2二种程序 ,剂量均为 1针 5 μg ,全程 3针 ,对 166例HBsAg和HBeAg单、双阳性母亲所生的新生儿和 491例HBsAg阴性母亲所生的新生儿进行免疫接种。结果全部观察对象未发现严重不良反应。 0、1、6和 0、1、2程序两组HBsAg阴性母亲的新生儿全程免疫后 6个月 ,抗 -HBs阳转率为 92 79%和 91 0 4% ;HBsAg和HBeAg单、双阳性母亲的新生儿抗 -HBs阳转率为 82 97%和 81 94% ;0、1、6和 0、1、2程序两组的阻断保护率分别为 81 0 8%和 81 48%。此结果表明 ,国产酵母重组乙肝疫苗具有较好的免疫效果和阻断乙肝母婴传播的保护作用 ,但乙肝母婴传播的阻断率仍有待于进一步提高。更多还原

【Abstract】 This study aimed to evaluate the immunological and the protective efficacy of the yeast recombinant hepatitis B vaccine(YRV)(China made)in clinical trials. 166 newborns whose mothers were HBsAg and/or HBeAg positive and 491 infants whose mothers had no HBV M were vaccinated with YRV of 5μg each dose by 0 1 6 or 0 1 2 month schedules. The YRV was proven safe and no serious side effect. The anti-HBs positive seroconversion rates in 0 1 6 group and 0 1 2 group(both were born from HBV M negative mothers)were 92.79% and 91.04% respectively at 6th month after three doses. The anti HBs positive seroconversion rates of infants whose mothers were HBsAg and/or HBe Ag positive in 0 1 6 group and 0 1 2 group were 82.97% and 81.94%, respectively. The rates of protective efficacy in 0-1-6 and 0-1-2 groups were 81.08% and 81.48% respectively. The results demonstrate the better immunogenicity and higher protective efficacy of China made YRV.更多还原