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目的 探讨成人基因重组乙型肝炎(乙肝)疫苗的免疫程序和免疫剂量。方法 选择射阳县盐东镇和盘湾镇一般健康状况良好的15～6 0岁、经筛查乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗体(抗HBs)、乙肝病毒核心抗体(抗 HBc)均为阴性的116 8名农民为对象,随机分为12个研究小组,选用重组(酵母)乙肝疫苗(5 μg、10 μg)、重组[中国仓鼠卵巢细胞(CHO细胞) ]乙肝疫苗(10 μg、2 0 μg)和0、1、2个月与0、1、6个月两种免疫程序进行免疫效果观察。结果 全程免疫后1个月时,12个组抗 HBs阳性率为72 . 83%～98 .99% ,抗 HBs几何平均滴度(GMT)为34 .4 5mIU/ml～2 0 .1 0 8mIU/ml;6个月时,12个组抗 HBs阳性率为5 5 . 0 0 %～95 . 10 % ,抗 HBsGMT为2 7. 0 1mIU/ml～81. 81mIU/ml。不同免疫方案之间抗HBs阳性率和GMT的差异均有非常显著的统计学意义。高剂量疫苗组抗 HBs阳性率、GMT和抗体高滴度分布比例均高于低剂量疫苗组;0、1、6个月程序抗HBs阳性率和GMT高于0、1、2个月程序;重组(CHO细胞)乙肝疫苗抗 HBs阳性率和GMT高于重组(酵母)乙肝疫苗,重组(CHO细胞)乙肝疫苗10 μg诱导的抗 HBsGMT显著优于10 μg重组(酶母)乙肝疫苗,但抗HBs阳性率差异无显著的统计学意义。结论 对成人开展乙肝疫苗接种应选择高剂量的乙肝疫苗,?
Objective To investigate the immunization schedule and immunization dose of adult recombinant hepatitis B (HBV) vaccine. Methods The patients in Yan Dong and Pan Wan townships of Sheyang County were generally healthy from 15 to 60 years old. The HBsAg, HBs, HBcAb (anti-HBc ) Were randomly selected from 12 experimental groups and selected recombinant (yeast) hepatitis B vaccine (5 μg, 10 μg) and recombinant [Chinese hamster ovary cell (CHO)] hepatitis B vaccine (10 μg, 20 μg) and immune effects of two immunization programs at 0, 1, 2 months and 0, 1, 6 months. Results The positive rate of anti-HBs in 12 groups was 72.83% -98.99% at 1 month after the whole immunization, and the geometric mean titers of anti-HBs (GMT) were 34.45mIU / ml ~ 2.010mIU / ml; 6 months, the positive rate of anti-HBs in 12 groups was 55.0% ~ 95.10%, anti-HBsGMT was 27.01mIU / ml ~ 81.81mIU / ml. The differences of anti-HBs positive rate and GMT between different immunization programs have very significant statistical significance. The positive rate of anti-HBs, GMT and high titer of antibody in high-dose vaccine group were higher than those in low-dose vaccine group. The positive rate of anti-HBs and GMT in 0, 1 and 6 months were higher than 0, 1 and 2 months. The positive rate of anti-HBs and GMT of recombinant hepatitis B vaccine (CHO) were higher than that of recombinant (yeast) hepatitis B vaccine. The anti-HBsGMT induced by 10 μg recombinant CHO vaccine was significantly better than 10 μg of recombinant hepatitis B vaccine, HBs positive rate difference was not statistically significant. Conclusion Hepatitis B vaccine should be selected for adult hepatitis B vaccination.