20μg重组乙型肝炎疫苗（酿酒酵母）在≥16岁人群中的免疫原性研究  

Surveillance of the immunogenicity of a 20μg/dose of hepatitis B vaccine made by recombinant deox-yribonucleic acid techniques in Saccharomyces cerevisiae （Hep B-SCY） in people aged 16 years and above

作　　者：陈海平 郭绍红 常国辉 马燕丽 孙走南 李丽 徐斌 董春明 杨云凯 

机构地区：[1]中国生物技术股份有限公司,北京100029 [2]北京天坛生物制品股份有限公司,100176 [3]解放军疾病预防控制所,北京210009

出　　处：《中华微生物学和免疫学杂志》2016年第11期855-858,共4页Chinese Journal of Microbiology and Immunology

摘　　要：目的：评价A公司生产的20μg重组乙型肝炎疫苗（酿酒酵母）上市后在≥16岁人群中的免疫原性。方法选择4636名乙肝病毒表面抗原阴性、抗乙肝病毒表面抗原抗体（ antibody to HBsAg, anti-HBs）〈100 mIU/ml的≥16岁的健康人群为观察对象,按0、1、6月免疫程序接种3剂20μg重组乙肝疫苗。采用化学微粒子发光法检测anti-HBs。结果免疫10 mIU/ml≤anti-HBs〈100 mIU/ml人群接种1剂和2剂20μg乙肝疫苗后anti-HBs免疫成功率和几何平均浓度分别为90.24%（703/779）、97.82%（449/459）和1314.35 mIU/ml、2065.96 mIU/ml；免疫前anti-HBs〈10 mIU/ml人群接种1剂、2剂和3剂20μg乙肝疫苗后anti-HBs免疫阳转率和高应答率（ anti-HBs≥100 mIU/ml）分别为69.16%（74/107）、86.13%（1975/2293）、98.72%（1844/1868）和50.47%（54/107）、56.43%（1294/2293）、87.53%（1635/1868）,anti-HBs几何平均浓度分别为47.68 mIU/ml、147.94 mIU/ml、649.15 mIU/ml。结论≥16岁的健康人群按照0、1、6免疫程序接种3剂20μg/ml重组乙型肝炎疫苗（酿酒酵母）具有良好的免疫原性。Objective To evaluate the immunogenicity of a 20 μg/dose of hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Saccharomyces cerevisiae （ Hep B-SCY ） in post-marketing stage among people aged 16 years and above. Methods This study recruited 4 636 healthy sub-jects aged 16 years and above, who were negative for hepatitis B surface antigen （ HBsAg） and the antibod-ies to HBsAg （ anti-HBs） in them were lower than 100 mIU/ml. The subjects were intramuscularly immu-nized with 20μg/dose of Hep B-SCY vaccine on a three-dose schedule （vaccination at months 0, 1 and 6）. The levels of anti-HBs were detected by chemiluminescence microparticle immunoassay （ CMIA ） . Results The anti-HBs immune success rates and the geometric mean concentrations （ GMCs） in subjects whose pre-immune anti-HBs titers were 〈100 mIU/ml and ≥10 mIU/ml were respectively 90. 24% （703/779）, 1 314. 35 mIU/ml and 97. 82%（449/459）, 2 065. 96 mIU/ml after 30 to 45 days of vaccination with 1 or 2 doses of the Hep B-SCY vaccine （20 μg/dose）. The antibody positive conversion rates, the highly response rates and the GMCs in subjects of pre-immune anti-HBs〈10 mIU/ml were respectively 69. 16%（74/107）, 50. 47%（54/107）, 47. 68 mIU/ml;86. 13%（1 975/2 293）, 56. 43%（1 294/2 293）, 147. 94 mIU/ml＆amp;nbsp;and 98. 72%（1 844/1 868）, 87. 53%（1 635/1 868）, 649. 15 mIU/ml after 30 to 45 days of vaccination with 1, 2 or 3 doses of the Hep B-SCY vaccine. Conclusion The post-marketing surveillance indicated that the three-dose schedule （vaccination at months 0, 1 and 6） of Hep B-SCY （20 μg /dose） showed good im-munogenicity in healthy people aged 16 years and above.

关 键 词：重组乙型肝炎疫苗(酿酒酵母) 16岁以上健康人群 免疫原性 

分 类 号：R186.2[医药卫生—流行病学]