| 张卫,林长缨,韩莉莉,李立秋,高培,林晖,龚晓红,黄芳,唐雅清,马建新,张海燕,王晨,杨鹏,李辉,孙美平,贺雄,庞星火.不同剂量国产重组酵母乙型肝炎疫苗成年人免疫效果及影响因素研究[J].Chinese journal of Epidemiology,2010,31(7):767-770 |
| 不同剂量国产重组酵母乙型肝炎疫苗成年人免疫效果及影响因素研究 |
| Study on the immuno-effects and influencing factors of Chinese Hamster Ovary (CHO) cell hepatitis B vaccine among adults, under different dosages |
| Received:December 29, 2009 |
| DOI： |
| KeyWord: 乙型肝炎疫苗 国产重组酵母 乙型肝炎表面抗体 随机双盲对照试验 多因素分析 |
| English Key Word: Recombinant CHO hepatitis B vaccine Anti-HBs Randomized double-blind controlled trials Multivariate analysis |
| FundProject:北京市科学技术委员会基金(Z000519004381 1)；“十一五”国家科技支撑计划(2008ZXl0002—001，2009ZXl0004—903) |
| Author Name | Affiliation | E-mail | | ZHANG Wei | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | LIN Chang-ying | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | HAN Li-li | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | LI Li-qiu | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | GAO Pei | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | LIN Hui | Beijing Center for Disease Control and Prevention, Beijing 100013, China | lihui99360@vip.sohu.com | | GONG Xiao-hong | Chinese Center for Disease Control and Prevention | | | HUANG Fang | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | TANG Ya-qing | Changping District Center for Disease Control and Prevention | | | MA Jian-xin | Chaoyang District Center for Disease Control and Prevention | | | ZHANG Hai-yan | Dongcheng District Center for Disease Control and Prevention | | | WANG Chen | Xuanwu District Center for Disease Control and Prevention | | | YANG Peng | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | LI Hui | Institute of Basic Medical Sciences Chinese Academy of Medical Sciences, School of Basic Medicine Peking Union Medical College | | | SUN Mei-ping | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | HE Xiong | Beijing Center for Disease Control and Prevention, Beijing 100013, China | | | PANG Xing-huo | Beijing Center for Disease Control and Prevention, Beijing 100013, China | beijingshifanqu@163.com |
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| Abstract: |
| 目的 通过随机双盲对照试验,评价10μg和20μg国产重组酵母(CHO)乙型肝炎(乙肝)疫苗应用于成年人的免疫效果,以及影响免疫效果的个体因素.方法 在北京市4个区县范围内选择18～45岁未接种乙肝疫苗、乙肝五项指标均为阴性的642名成年人作为研究对象,随机分为两组,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,以雅培化学发光的方法检测抗-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,利用logistic回归分析方法分析影响抗-HBs阳转的个体因素.结果 10μg和20μg两个剂量组抗-HBs阳转率分别为88.8%(95%CI:85.4%～92.2%)和95.3%(95%CI:93.0%～97.6%).按照抗-HBs＜100 mIU/ml为低无应答标准,低无应答率分别为34.3%和17.4%;抗体几何平均滴度(GMT)分别为173.42 mIU/ml和588.51 mIU/ml.多因素分析表明:患糖尿病、配偶为乙肝病毒感染者以及大年龄组人群是抗体阳转不利因素,而20μg疫苗剂量有利于抗体阳转.结论 CHO乙肝疫苗20μg免疫效果优于10μg,乙肝疫苗免疫效果评价应考虑多因素的影响. |
| English Abstract: |
| Objective To evaluate the immuno-effect and related influencing factors on 10 μg and 20 μg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population. Methods A total of 642 adults aged 18-45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 tg and 20 μg recombinant CHO hepatitis B vaccination by 0-1-6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject. Results The anti-HBs seroconversion rates on 10 μg and 20 μg dose groups were 88.8%(95%CI: 85.4%-92.2%) and 95.3%(95%CI: 93.0%-97.6%)respectively. Taking the anti-HBs level＜100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers(GMT)of anti-HBs were 173.42 mIU/ml for the 10 μg dose group and 588.51 mIU/ml for the 20 μg dose group. Data from the Multivariate analysis showed that: diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 μg dose of the vaccine was conducive to seroconversion.Conclusion 20 μg CHO hepatitis B vaccine seemed better than 10 μg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines. |
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