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目的采用不同免疫程序,评价成人接种重组乙型肝炎(乙肝)疫苗(汉逊酵母)[Recombinant Hepatitis B Vaccine(Hansenula polymorpha),Hep B]的免疫效果。方法选择柯桥区年龄在16~49岁的健康成人且无Hep B接种史和接种禁忌,实验室筛检乙肝病毒(Hepatitis B Virus,HBV)标志物乙肝病毒表面抗原(HBV Surface Antigen,Hbs Ag)、抗乙肝病毒表面抗原抗体(Antibody to Hbs Ag,Anti-HBs)、抗乙肝病毒核心抗原抗体(Antibody to HBV Core Antigen,Anti-HBc)均阴性。所有研究对象均进行问卷调查。3个乡镇分别选用“0-1-3月”、“0-1-6月”、“0-1-12月”免疫程序,接种完成1个月后检测Anti-HBs阳性率、抗体滴度水平进行评价。比较不同免疫程序免疫后的Anti-HBs阳性率、抗体滴度水平。采用多因素分析方法确定排除其他因素影响后,免疫程序对抗体应答的影响。结果 “0-1-3月”、“0-1-6月”、“0-1-12月”各组Anti-HBs阳转率分别为98.01%、98.43%、93.65%,差异有统计学意义(χ~2=7.70,P<0.05)。各组Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为807.89 m IU/ml、930.68 m IU/ml、720.28 m IU/ml,差异无统计学意义(K=0.32,P=0.85)。多因素分析显示,在排除性别、年龄等影响因素后,抗体水平与免疫程序无关。结论成人Hep B“0-1-3月”、“0-1-6月”、“0-1-12月”免疫程序均可获得较好的抗体应答,“0-1-3月”和“0-1-6月”组阳转率略高于“0-1-12月”组,其长期效果需进一步随访。
Objective To evaluate the immunological effects of recombinant hepatitis B vaccine (Hesenula polymorpha) and Hep B in adults vaccinated with different vaccination protocols. Methods A healthy adult aged 16-49 years old from Keqiao District were selected and had no history of vaccination and contraindications to vaccination. Hepatitis B Virus (HBV) markers such as hepatitis B virus surface antigen (HBsAg) ), Anti-HBs (Anti-HBs) and anti-HBV Core Antigen (Anti-HBc) were all negative. All subjects were surveyed. Three villages and towns were selected “0-1-3 month ”, “0-1-6 June ”, “0-1-12 month ” immunization program, one month after the completion of vaccination to detect Anti-HBs Positive rate, antibody titer levels were evaluated. Anti-HBs positive rate and antibody titer after immunization were compared. Multivariate analysis was used to determine the effect of the immunization schedule on antibody response after exclusion of other factors. The results showed that the positive rate of Anti-HBs in each group was 98.01%, 98.43%, 93.65%, respectively. The positive rate of Anti-HBs in “0-1-3 months”, “0-1-6 months”, “ %, The difference was statistically significant (χ ~ 2 = 7.70, P <0.05). The Geometric Mean Concentration (GMC) of Anti-HBs in each group were 807.89 m IU / ml, 930.68 m IU / ml and 720.28 m IU / ml respectively. There was no significant difference (K = 0.32, P = 0.85). Multivariate analysis showed that the antibody level had nothing to do with the immune procedure after excluding the influencing factors such as gender and age. Conclusion Adult Hep B can get better antibody response with the ”0-1-3M“, ”0-1-6M,“ ”0-1-12M“ immunization procedures, and ”0“ - 1-3 months ”and“ 0-1-6 months ”group positive rate slightly higher than the“ 0-1-12 months ”group, its long-term effect needs further follow-up.