不同重组乙型肝炎疫苗应用于成人后乙型肝炎病毒表面抗体动态观察

Observation on the Anti-HBs of Different Genetic Engineering Hepatitis B Vaccine in Adults

目的观察不同重组乙型肝炎(乙肝)疫苗和0、1、6个月免疫程序应用于成人后,乙肝病毒表面抗体(抗-HBs)的动态变化。方法按照重组乙肝疫苗应用于成人免疫剂量和免疫程序研究的结论,对应用重组乙肝疫苗[中国仓鼠卵巢细胞(CHO细胞)]20μg和0、1、6个月免疫程序免疫的成人,于全程免疫后1年、2年检测抗-HBs,并以重组乙肝疫苗(CHO细胞)10μg和重组乙肝疫苗(酵母)10μg的免疫对象作为对照予以比较。结果重组乙肝疫苗(CHO细胞)20μg全程免疫后1年的抗-HBs阳性率和几何平均浓度(GMC)分别为97.1%、85.06亳国际单位/亳升(mIU/ml),而重组乙肝疫苗(CHO细胞)10μg和重组乙肝疫苗(酵母)10μg的抗-HBs阳性率和GMC分别为73.2%、32.94mIU/ml和65.8%、30.74mIU/ml。全程免疫后2年,重组乙肝疫苗(CHO细胞)20μg的抗-HBs阳性率和GMC分别为89.9%、52.23mIU/ml,而重组乙肝疫苗(CHO细胞)10μg和重组乙肝疫苗(酵母)10μg的抗-HBs阳性率和GMC分别为69.6%、22.17mIU/ml和63.6%、22.02mIU/ml。不同重组乙肝疫苗免疫后的抗-HBs阳性率和GMC差异均有显著的统计学意义,且重组乙肝疫苗(CHO细胞)20μg免疫后的抗-HBs阳性率和GMC明显优于重组乙肝疫苗(CHO细胞)10μg和重组乙肝疫苗(酵母)10μg;重组乙肝疫苗(CHO细胞)10μg和重组乙肝疫苗(酵母)10μg的差异无显著的统计学意义。结论重组乙肝疫苗(CHO细胞)20μg应用于成人后,抗-HBs阳性率和GMC维持在较高水平。因此,成人接种乙肝疫苗建议优先使用重组乙肝疫苗(CHO细胞)20μg。

Objective To observe the anti-HBs of different genetic engineering Hepatitis B vaccine in adults of 0-1-6 months. Methods According to the conclusions on the immune schedule and doses of genetic engineering Hepatitis B vaccines in adults,anti-HBs was tested in adults of 0-1-6 months with recombinant Hepatitis B vaccine （CHO cells） 20 μg after 1 and 2 years vaccinating. Meanwhile comparative analysis anti-HBs of recombinant Hepatitis B vaccine （CHO cells） with 10μg and recombinant Hepatitis B vaccine （yeast-derived） with 10μg. Results After 1 year that immunization program was completed,the anti-HBs positive rates of recombinant Hepatitis B vaccine （CHO cells） with 20μg was 97.1% and GMC was 85.06mIU/mL,and its recombinant Hepatitis B vaccine （CHO cells） with 10 μg was 73.2% and GMC was 32.94 mIU/ mL,its recombinant Hepatitis B vaccine （yeast-derived） with 10 μg was 65.8% and GMC was 30. 74mIU/mL. After 2 years that immunization program was completed, the anti-HBs positive rates of recombinant Hepatitis B vaccine （CHO cells） with 20μg was 89.9% and GMC was 52.23 mIU/mL,and its recombinant Hepatitis B vaccine （CHO cells） with 10 μg was 69.6% and GMC was 22.17 mIU/mL,its of recombinant Hepatitis B vaccine （yeast-derived） with 10μg was 63.6% and GMC was 22.02 mIU/mL. The anti-Bs positive rates and GMC in 3 vaccines had highly significant difference. The anti-HBs positive rates and GMT of recombinant Hepatitis B vaccine （CHO cells） with 20 μg were higher than those of recombinant Hepatitis B vaccine （CHO cells） with 10 g and recombinant Hepatitis B vaccine （yeast-erived） with 10 g,but recombinant Hepatitis B vaccine （CHO cells） with 10 g had no significant difference than recombinant Hepatitis B vaccine yeast-erived） with 10 μg. Conclusions It shows that recombinant Hepatitis B vaccine （CHO cells） with 20 μg should use for adults and the anti-Bs positive rates and GMC kept higher. It is suggested that recombinant Hepatitis B vaccine （CHO cells） with 20 g were taken precedence to select.