不同剂量国产重组酵母乙肝疫苗成人免疫效果评价  

Evaluation of the immune effect of Chinese hamster ovary cell derived hepatitis B vaccine among adults

作　　者：刘重程[1] 唐雅清[1] 王瑞琴[1] 隋吉林[1] 蔡旭[1] 张卫[2] 

机构地区：[1]北京市昌平区疾病预防控制中心,北京102200 [2]北京市疾病预防控制中心

出　　处：《中国预防医学杂志》2012年第9期701-703,共3页Chinese Preventive Medicine

摘　　要：目的评价10μg和20μg国产重组酵母(CHO)乙型肝炎(乙肝)疫苗成年人的免疫效果。方法在北京市昌平区选取两个自然村,选择18～45岁未接种乙肝疫苗、乙肝五项指标均为阴性的222名成年人作为研究对象,随机分为两组,双盲对照,按照"0-1-6"程序分别接种10μg和20μg CHO乙肝疫苗。通过问卷方法调查每个对象可能影响乙肝疫苗免疫效果的个体因素。于接种第三针1个月后采血,以化学发光方法检测抗-HBs滴度值,抗-HBs阴性者采用荧光定量PCR方法进一步检测HBV DNA。结果 10μg和20μg两个剂量组抗-HBs阳转率分别为89.47%(95%CI:83.75%～95.19%)和99.07%(95%CI:97.24%～100.00%),抗体几何平均滴度(GMT)分别为134.57IU/L和921.11IU/L,差异有统计学意义(P值分别为0.02和0.00)。结论 CHO乙肝疫苗有较好的安全性和免疫原性,20μg是成人免疫的最佳剂量。Objective To evaluate the immune effect of Chinese hamster ovary （CHO） cell derived hepatitis B vaccine among adults vaccinated with either 10μg or 20fig dosage using the randomized double blind controlled trials in adult population. Methods A total of 222 adults aged 18 to 45 years who had been never vaccinated and were negative for all five HBV markers, were selected into the study from two villages in Changping dis trict. They were randomly assigned into two groups with double blinded and were given 10μg or 20μg recombi nant CHO derived hepatitis B vaccine according to a 0-1-6 month schedule. Blood samples were collected one month after the third shot to detect the anti-HBs antibody by Abort chemiluminescence method. For those an- tibody negative samples, fluorescent quantitative PCR was further used to amplify HBV DNA. Results The anti-HBs antibody seroconversion rates and the geometric mean titers （GMT） in 10μg and 20μg dose vaccinat edgroups were 89.47% （95%CI： 83.75%-95.19%）, 99.07% （95%CI： 97.24%-100.00%） and 134.57 IU/L, 921.11 IU/L respectively. There were a significant differences between the two dose groups （P= 0.02, P=0.01）. Conclusions The CHO cell derived hepatitis B vaccine is effective and safe to adults and 20μg is the optimal dose for adult immunization.

关 键 词：重组酵母乙型肝炎疫苗 表面抗体 免疫效果评价 

分 类 号：R512.62[医药卫生—内科学] R186[医药卫生—临床医学]