广东新生儿接种重组乙型肝炎疫苗的免疫效果

[目的]观察新生儿接种重组酵母乙型肝炎(乙肝)疫苗后的免疫持久性及预防效果.[方法]采用前瞻性研究的方法,对166例广东新生儿接种重组酵母乙肝疫苗后的免疫应答情况及副作用进行定群随访.按母亲是否为HBsAg阳性,将观察对象分为HBsAg阳性组31例及HBsAg阴性组135例、比较两组抗HBs的产生情况及副作用.[结果]①幼儿1岁时,总应答率为90.4%(150/166).HBsAg阳性组和HBsAg阴性组的应答分别为25例(80.6%)和125例(92.6%),比值比(OR)及其95%可信区间为0.33(0.11,1.00),差异无统计学意义.②幼儿3岁时,总应答率为92.2%(153/166).HBsAg阳性组和HBsAg阴性组的应答分别为26例(83.9%)和127例(94.1%),OR=0.33(0.10,1.08),差异无统计学意义.③1岁时产生应答的155例新生儿中,在3岁时均无抗HBs阴转现象.HBsAg阳性组和HBsAg阴性组的无反应儿在补种疫苗后的应答率分别为25%(1/4)和20%(2/10).④疫苗接种过程中无严重不良反应.[结论]国产重组酵母乙肝疫苗具有良好的安全性及近期保护效果.

Immune Effect of Recombinant HBV Vaccine for Newborn from Guangdong

To observe the persistent protective effect of HBV vaccine of recombination yeast for newborn from Guangdong. A prospective study was performed to observe the immune response and side effects of HBV vaccine of recombination yeast for 166 newborn from Guangdong after a cohort follow-up. The objects were divided into mother HBsAg(+) group and mother HBsAg(-) group. The Anti-HBs positive rates and side effects were compared between two groups. (1) The total response rate was 90.4% (150/166) at the age of one. The response rate had no significant difference between two groups (80.6% vs 92.6%, P > 0.05) with the odds ratio (OR) and its 95% confidence interval (95%CI) of 0.33 (0.11, 1.00). (2) The total response rate was 90.4% (150/166) at the age of three, with no significant difference of response rate between HBsAg(+) group and HBsAg(-) group [83.9% vs 94.1%, P >0.05; OR=0.33 (0.10,1.08)]. (3) One hundred and fifty responders at the age of one all kept Anti-HBs(+) till they were three years old. After complementary vaccination, the response rates of the original non-responders were 25% (1/4) and 20% (2/10) in HBsAg(+) group and HBsAg(-) group, respectively. (4) No serious side effect was found. [Conclusion]This HBV vaccine of combination yeast could induce anti-HBs response and was safe.