成人接种20微克重组乙型肝炎疫苗免疫应答及其影响因素的比较研究  

Comparison on the Antibody Response and Influenced Factors of Hepatitis B Vacine Made by Recombinant Dexyribonucleic Acid Techniques among Adults

作　　者：刘甲野[1] 颜丙玉[1] 张丽[1] 吕静静[1] 冯艺[1] 纪峰[1] 陈世玉[2] 徐爱强[1] 

机构地区：[1]山东省疾病预防控制中心,山东省预防控制传染性疾病重点实验室,济南250014 [2]章丘市疾病预防控制中心,山东章丘250200

出　　处：《中国疫苗和免疫》2013年第2期142-146,153,共6页Chinese Journal of Vaccines and Immunization

基　　金：国家科学技术重大专项艾滋病和病毒性肝炎等重大传染病防治专项"我国乙型病毒性肝炎免疫预防策略研究"课题(编号:2008ZXl0002-001);国家科学技术重大专项艾滋病和病毒性肝炎等重大传染病防治专项"山东省乙型病毒性肝炎防治综合示范区规模化现场流行病学和干预研究"课题(编号:2009ZXl0002-028);山东省医药卫生青年基金项目"成人乙型肝炎疫苗免疫效果评价和影响因素分析"(编号:2009QZ017)

摘　　要：目的比较成人接种20微克(g)重组乙型肝炎(乙肝)疫苗(中国仓鼠卵巢细胞)[Hepatitis B Vaccine(HepB)Made by Recombinant Deoxyribonucleic Acid(DNA)Techniquesin Chinese Hamster Ovary(CHO)Cell,HepB-CHO]和20g重组乙肝疫苗(酿酒酵母)(HepB Made by Recombinant DNA Techniquesin Saccharomyces Cerevisiae Yeast,HepB-SCY)的抗体应答及其影响因素。方法在山东省章丘市选择研究现场,筛选出乙肝病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]、抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)和抗乙肝病毒核心抗原抗体全阴性者作为研究对象,随机分为两组,按照0、l、6个月免疫程序分别接种20g HepB-SCY和20g HepB-CHO。所有研究对象进行问卷调查并采集静脉血,采用化学发光微粒子免疫分析法(Chemiluminescence Microparticle Imunoassay,CMIA)定量检测Anti-HBs。比较不同HepB初次免疫后的抗体应答率和抗体水平,采用多因素分析方法确定排除其他因素影响后,HepB种类对抗体应答的影响。结果 HepB-SCY和HepB-CHO分别接种2011人和2290人。HepB-SCY无应答[<l0毫国际单位/毫升(mIU/m1)]率、低应答[10mIU/ml～99mIU/ml]率、正常应答[100mIU/ml～999mIU/m1]率、高应答[≥1000mIU/ml]率分别为14.22%、15.57%、29.09%和41.12%,HepB-CHO分别为9.35%、19.08%、33.97%和37.60%,两组四项指标间差异均有统计学意义(x2=5.44～23.11,P<0.01)。HepB-SCY组和HepB-CHO组Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为270.39mIU/ml[95%可信区间(Confidence Interval,CI):233.33mIU/ml～3l3.32mIU/m1]和312.67mIU/ml(95%CI;278.28mIU/ml～351.32mIU/ml),差异无统计学意义(U=I.52,P=0.13)。多因素分析显示,排除性别、年龄、体重指数、吸烟史、饮酒史等因素影响后,无应答率与疫苗种类有关。结论成人接种20g HepB-SCY和20gHepB-CHO均可以获得较好的抗体应答,20g HepB-SCY无应答率略高于20g HepB-CHO。Objective To compare the antibody response induced by 20μg hepatitis B vaccine （HepB） made by recombinant dexyribonucleic acid （DNA） techniques in saccharomyces cerevisiae yeast （HepB- SCY） and 20μg HepB made by recombinant DNA techniques in Chinese hamster ovary （CHO）cell （HepB-CHO） and influenced factors among the adults. Methods Healthy adults who were negative for hepatitis B virus （HBV） surface antigen （HBsAg）, antibody to HBsAg （ Anti-HBs ） and antibody to HBV core antigen （Anti-HBc） were selected from Zhangqiu county Shandong province. They were divided into two groups randomly and were vaccinated following the schedule of 0-1- 6 with 20ktg HepB-SCY and 201.tg HepB-CHO respectively. Questionare investigation was made and blood samples were collected for each person. Anti-HBs was detected by chemiluminescence microparticle imunoassay （CMIA）. Seroconversion rate and geometric mean concentrations （GMC）of Anti-HBs were compared between the two groups. Multivariate analysis was used to find the relationship between the kind of HepB and seroconversion rate or GMC of Anti-HBs after debugging the other influencing factors including age, gender, body mass index, smoking history and drinking history. Results 2011 adults received 20μg HepB-SCY （HepB-SCY group）and 2290 adults received 20gg HepB CHO （HepB-CHO group）. In HepB-SCY group, the rates of non-, low-, normal-and high-response were 14.22%, 15.57%, 29.09% and 41.12% respectively. In HepB-CHO group, the corresponding rates were 9.35%, 19.08%, 33.97% and 37.60% respectively. The above four rates showed significant differences between the two groups （χ2=5.44-23.11, P〈0.01 ）. The GMCs of Anti-HBs were 270.39mIU/ml （95 % CI ：233.33 mIU/ml-313.32 mIU/ml ）and 312.67mIU/ ml（95% CI ： 278.28 mIU/ml-351.32 mIU/ml ）in 20lag HepB-CHO group and in 20btg HepB-CHO group respectively and the confidence interval was not statistically significant （u= 1.52, P=0.13 ）. Multivariate analysis showed that the

关 键 词：成人 重组乙型肝炎疫苗(中国仓鼠卵巢细胞) 重组乙型肝炎疫苗(酿酒酵母) 抗体应答 

分 类 号：R186[医药卫生—流行病学] R512.62[医药卫生—公共卫生与预防医学]