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目的探讨重组乙型肝炎(乙肝)疫苗(酵母)对成人的免疫原性。方法在济阳县乡村随机整群选择健康的15~40岁乙肝病毒(HBV)易感者591人,按0、1、6个月和0、6个月免疫程序,接种广东省深圳康泰生物制品有限公司生产的重组乙肝疫苗(酵母),每剂10μg/1.0ml。结果全程免疫后1个月时,0、1、6个月和0、6个月两种免疫程序的有效乙肝病毒表面抗体(抗-HBs)阳转率分别为95.91%、86.08%,两种免疫程序产生有效抗-HBs,抗体几何平均浓度(GMC)分别为332.5毫国际单位/毫升(mIU/ml)(95%CI为279.17mIU/ml~396.03mIU/ml)和227.4mIU/ml(95%CI为186.34mIU/ml~277.51mIU/ml)。0、1、6个月免疫程序的有效抗-HBs阳转率和GMC均高于0、6个月程序,差异有显著的统计学意义。结论10μg/ml重组乙肝疫苗(酵母)接种15~40岁人群的免疫原性良好,其长期效果需进一步随访。
Objective To investigate the immunogenicity of recombinant hepatitis B (hepatitis B) vaccine (yeast) in adults. Methods A total of 591 HBV-susceptible individuals (aged 15-40 years) were randomly selected from villages in Jiyang County. According to the immunization schedule of 0, 1, 6 months and 0, 6 months, Products Co., Ltd. produced recombinant hepatitis B vaccine (yeast), each dose of 10μg / 1.0ml. Results The positive rate of anti-HBs positive rates of the two immunization programs at 0, 1, 6 months and 0, 6 months were 95.91% and 86.08% at 1 month after the whole immunization, respectively The immunization schedule yielded potent anti-HBs with antibody mean geometric mean concentrations (GMC) of 332.5 milliUU / ml (95% CI, 279.17 mIU / ml to 396.03 mIU / ml) and 227.4 mIU / ml % CI was 186.34 mIU / ml to 277.51 mIU / ml). The effective anti-HBs positive rate and GMC in 0, 1, and 6-month immunization programs were all higher than those in 0 and 6 months, with significant differences statistically significant. Conclusion The immunogenicity of 10μg / ml recombinant hepatitis B vaccine (yeast) vaccinated in 15 ~ 40 years old population is good, and its long-term effect needs further follow-up.