重组(酵母)乙型肝炎疫苗免疫后5年随访结果

A Five-year Follow-up study of HBV DNA Recombinant Vaccine.

目的探讨新生儿接种国产重组(酵母)乙型肝炎(乙肝)疫苗后的免疫效果,并与血源乙肝疫苗效果比较。方法对1997年出生并接种重组(酵母)乙肝疫苗的新生儿隔年随访一次,采血检测乙肝病毒表面抗原(HBsAg),乙肝病毒表面抗体(抗-HBs)和乙肝病毒核心抗体(抗-HBc),1998年以后对乙肝免疫人群开展急性乙肝发病监测。结果 5年期间3次随访检测HBsAg阳性率平均为1.50%,较免前本底的HBsAg阳性率呈较大幅度下降,疫苗保护率为83.00%(95%可信区间为76.97%～89.02%),无论母亲HBsAg阳性或阴性,使用不同乙肝疫苗的儿童HBsAg阳性率差异没有统计学意义。接受重组(酵母)乙肝疫苗免疫的对象中,无一例急性乙肝病例报告。结论重组(酵母)乙肝疫苗有较好的近期保护效果和免疫原性,与以往使用血源乙肝疫苗相当。

Objective To study immune efficacy of domestic HBV DNA recombinant vaccine given to infants and compare with plasma-derived one.Methods Every two years we tested HBsAg,anti-HBs and anti-HBc of blood taken from infants who were born in 1997 and were vaccinated with HBV DNA recombinant vaccine at their birth.After 1998,we monitored the incidence of acute hepatitis B in subjects with hepatitis B vaccine vaccinated.Result Average positive rate of HBsAg in three follow-up surveys during 5 years is about 1.50 % and dropped greatly compared with that before inoculation.Vaccine protective ratio is 83.00 %（95 %confident interval is between 76.97 %～89.02 %）.The HBsAg positive rates of subjects who received different hepatitis B have no statistical difference no matter the HBsAg of their mothers is positive or negative.Acute hepatitis B is not found in subjects inoculated with HBV DNA recombinant vaccine.Conclusion HBV DNA recombinant vaccine has good short-term immunogenicity and protective efficacy which is equal to that of plasma-derived one.