Zhang Wei, Lin Chang-ying, Han Li-li, Li Li-qiu, Gao Pei, Lin Hui, Gong Xiao-hong, Huang Fang, Tang Ya-qing, Ma Jian-xin, Zhang Hai-yan, Wang Chen, Yang Peng, Li Hui, Sun Mei-ping, He Xiong, Pang Xing-huo
Beijing Center for Disease Control and Prevention, Beijing 100013 China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2010 Jul;31(7):767-70.
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.
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 µg 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.
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.
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.
采用随机双盲对照试验，在成年人群中评估10μg和20μg中国仓鼠卵巢（CHO）细胞乙型肝炎疫苗的免疫效果及相关影响因素。
从北京四个区选取642名18 - 45岁未接种过乙型肝炎疫苗且五项乙肝血液指标均为阴性的成年人作为研究对象。将研究对象随机分为两组，然后按照0 - 1 - 6月程序分别接种10μg和20μg重组CHO乙型肝炎疫苗。通过问卷调查方式调查影响因素。在第三剂疫苗接种后1个月采集血样；采用雅培化学发光检测法检测抗-HBs水平。对于抗-HBs阴性者，采用荧光定量PCR法检测其是否感染过HBV。采用Logistic回归分析各研究对象抗-HBs血清转化的影响因素。
10μg和20μg剂量组的抗-HBs血清转化率分别为88.8%（95%CI：85.4% - 92.2%）和95.3%（95%CI：93.0% - 97.6%）。以抗-HBs水平<100 mIU/ml作为低/无应答标准，低应答率和无应答率分别为34.3%和17.4%。10μg剂量组抗-HBs的几何平均滴度（GMT）为173.42 mIU/ml，20μg剂量组为588.51 mIU/ml。多因素分析数据显示：糖尿病、配偶感染乙肝病毒和年龄较大是抗-HBs血清转化的不利因素；20μg剂量疫苗有利于血清转化。
20μg CHO乙型肝炎疫苗似乎优于10μg CHO乙型肝炎疫苗，但评估乙型肝炎疫苗时需要考虑诸多因素。
