高危新生儿接种酶母重组乙肝疫苗12年效果

[目的]评价接种酶母重组乙肝疫苗（基因疫苗）的免疫效果与免疫持久性，为基因疫苗的推广应用及高危新生儿乙型肝炎的预防提供依据。[方法]1985年－1986年HBsAg( ）产妇93例及所生的新生儿94例，按0，1，6免疫程序接种美国Merck基因疫苗（5μg/剂），分别于免疫接种后6个月，12个月及12周岁后采血放射免疫法（RIA）作HBsAg及抗－HBs检测。[结果]新生儿接种基因疫苗12年后，母亲HGsAg阳性但HBeAg阴性者（单阳性）的HBsAg阳性率为4．17％，显著低于母亲HBsAg及HBeAg均阳性者（双阳性）的23．40％（P＜0．05）。两组对象12周岁时的免疫保护率分别为91．66％与74．00％，联合使用乙肝免疫球蛋白（HBIG）并未显示出能提高基因疫苗接种者的HBsAg阻断率及抗－HBs血清阳转率（P＞0．05）。[结论]Merck基因疫苗的短期和远期免疫效果可以肯定，其对于乙肝高危产妇所生儿童的有效保护率至少可以持续１２年，联合使用ＢＨＩＧ并不增加基因疫苗的长期免疫效果，基因疫苗可以取代乙肝血源疫苗，并将在乙肝免疫预防中发挥重要的作用。

The Efficacy ofYeast-recombinant Hepatitis B Vaccine: A 12-year Observation in High-risk Newborns

To assess the immunogenecity and efficacy of the yeast recombinant hepatitis B vaccine (YHB vaccine) for the prevention of hepatitis B in the newborns. Ninety four neonates, born in 1985 and 1986, whose mothers with positive for hepatitis B surface antigen (HBsAg) or/and envelope antigen (HBeAg) received 5 micrograms of a YHB vaccine (Merck) at 0, 1, and 6 month. Blood samples were taken at month 6, 12, and year 12, and HBsAg and anti HBs were detected by radioimmunoassay (RIA). According to the 12th year's blood test, the positivity for HBsAg in neonates born to HBsAg carriers (4.17%) was significantly lower than that in those born to both HBsAg and HBeAg positive mothers (23.40%,P<0.05). The protective efficacy at year 12 were 91.66% and 74.00%, respectively. No differences were seen for the HBsAg seropositive and anti HBs seroconversion rate between children who received three 5 micrograms doses of YHB vaccine only and those in combination with hepatitis B immunoglobulin (HBIG) at birth.[Conclusion] The data obtained suggests that, in this high risk setting, the Merck YHB vaccine is regarded as immunogenic and effective, and the protection can persist at least until age of 12 years. HBIG does not improve the long term immune efficacy of the YHB vaccine. YHB vaccine can replace plasma derived Hepatitis B Vaccine for the prevention of mother infant transmission of hepatitis B virus.