某矿区人群接种重组酵母乙肝疫苗免疫效果分析

Evaluation of Immunogenicity of Recombinant Yeast-Derived Hepatitis B Vaccine in Population of A Coal-mine Area

目的了解重组酵母乙肝疫苗(recombinant yeast-derived hepatitis B Vaccine,YDV)在不同年龄组人群中的免疫学效果和安全性。方法选择兖矿集团某矿区0～62岁的903名乙型肝炎表面抗原(HBsAg)、乙型肝炎表面抗体(抗-HBs)和乙型肝炎核心抗体(抗-HBc)三项指标均为阴性者,采用0-1-6的免疫程序接种YDV,分别于全程接种后1、12、24、36个月时检测血清HBsAg和抗-HBs。结果研究对象接种后3d内未发现中重度的局部和全身不良反应。全程免疫后第1、12、24、36个月,抗-HBs阳转率分别为86.71%、71.85%、50.23%、41.25%(χ2=477.27,P<0.01),呈逐年下降趋势(P<0.01);经年龄标准化后,女性抗-HBs阳转率在各阶段均高于男性,但无统计学意义(P>0.05);人群抗-HBs阳转率与年龄有着密切关系,随年龄升高而逐渐降低(P<0.05)。结论YDV具有良好的免疫源性和安全性。

Objective To study the safety and the immunogenicity of recombinant yeast-derived hepatitis B vaccine （YDV） in population of a coal-mine area. Method 903 individuals of age 0-62 years old and were all negative for HBsAg, anti-HBs and anti-HBc were selected by simple cluster sampling from the Yan Coal-mine Group. They were vaccinated with 5μg/0.5 ml YDV at 0, 1 and 6 months, and were tested for HBsAg and anti-HBs at the 1^th, 12^th, 24^th and 36^th month after the final vaccination. Result The positive rate of anti-HBs were 86.71%,71.85%, 50.23% and 41.25%（X^2=477.27 ,P〈0.01 ） at the 1^th, 12^th ,24^th and 36^th month after the final vaccination, respectively. The positive rate of anti-HBs decreased year by year （P〈 0.01）. Though the positive rate of anti-HBs at different month in the female was higher than that in the male, age-standardized significant difference was not observed. With increase in age, the positive rate of anti-HBs decreased（P〈0.05）. Conclusion The YDV is effective and safe.