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目的评价不同剂量重组乙型病毒性肝炎(乙肝)疫苗(hepatitis B vacc ine,HepB)对母亲乙肝病毒表面抗原(HBsAg)阳性新生儿的免疫效果。方法选择2005-2007年孕期或住院分娩时检测HBsAg阳性母亲的新生儿637例,分5、10、20μg三组分别接种相应剂量重组HepB,免后1~6月采血,使用微粒子酶免疫测定法检测HBsAg、化学发光法检测乙肝病毒表面抗体(抗-HBs)。结果 5μg组新生儿HBsAg阳性率为3.80%、抗-HBs阳性率为66.30%;10μg组新生儿HBsAg阳性率为4.64%、抗-HBs阳性率为89.29%;20μg组新生儿HBsAg阳性率为2.89%、抗-HBs阳性率为91.33%。3种剂量免后HBsAg阳性率差异无统计学意义(χ2=0.881,P=0.644),抗-HBs阳性率差异有统计学意义(χ2=53.183,P(0.001),10μg组和20μg组的抗-HBs阳性率及几何平均浓度明显高于5μg组。结论采用10μg重组酵母HepB或20μg重组HepB(中国仓鼠卵巢细胞,CHO)接种为适宜方案。
Objective To evaluate the immunogenicity of Hepatitis B virus (HBsAg) positive mothers with different doses of recombinant hepatitis B virus (HepB). Methods Six hundred and sixty-three neonates with HBsAg-positive mothers during pregnancy or hospital delivery during 2005-2007 were enrolled in this study. The corresponding doses of recombinant HepB were inoculated into 5, 10, and 20 μg groups, respectively. Blood samples were collected from January to June after immunization with microparticle enzyme immunoassay Detection of HBsAg, chemiluminescence detection of hepatitis B virus surface antibodies (anti-HBs). Results The positive rate of HBsAg in newborns was 3.80% and the positive rate of anti-HBs was 66.30% in 5μg group. The positive rate of HBsAg in newborns was 4.64% in 10μg group and 89.29% in HBsAg in newborns. The positive rate of HBsAg in 20μg group was 2.89 %, Anti-HBs positive rate was 91.33%. There was no significant difference in the positive rate of HBsAg between the three doses (χ2 = 0.881, P = 0.644), the positive rate of anti-HBs was statistically significant (χ2 = 53.183, P (0.001) -HBs positive rate and the geometric mean concentration were significantly higher than the 5μg group.Conclusion The appropriate program using 10μg recombinant HepB or 20μg recombinant HepB (Chinese hamster ovary cells, CHO) inoculation.