Zhang Wei, Han Li-li, Lin Chang-ying, 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, Wu Jiang, Sun Mei-ping, He Xiong, Pang Xing-huo
Beijing Center for Disease Control and Prevention, Beijing, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2010 Oct;44(10):918-22.
To evaluate the cellular and humoral immunity effect of 10 µg and 20 µg recombinant Chinese hamster ovary (CHO) cell hepatitis B vaccine in adults by randomized double-blind controlled trials.
A total of 642 adults aged 18 - 45 years old, non-vaccinated against hepatitis B, and hepatitis B five blood indicators negative were selected as the study subjects. The study subjects were randomly divided into two groups and each group had 321 subjects. The subjects were given 10 µg and 20 µg recombinant CHO hepatitis B vaccination respectively by 0, 1st, 6th month schedule. Blood sample was collected from each study subject one month after the second dose vaccination. The anti-HBs level was detected by Abbott chemiluminescence detection method (I2000) to evaluate humoral immunity status. Of all the study objects, 153 cases were randomly selected by the Excel random function. Their blood samples were collected and Lymphocyte were separated to detect the IL-4 and IFN-γ levels in vitro by enzyme-linked immunospot (ELISPOT) method to evaluate the cellular immunity status.
The anti-HBs seroconversion rates in 10 µg and 20 µg dose group were 88.8% (285/321) and 95.3% (306/321) respectively, and 95%CI were 85.4% - 92.2% and 93.0% - 97.6% respectively. The spot forming cell (SFC) of IL-4 of the 20 µg-dose group (x(-) = 20.31) were significantly higher than the 10 µg-dose group (x(-) = 8.19, t = 3.27, P < 0.01). With the increasing of anti-HBs titer, the SFC of IL-4 also went up significantly. There was a positive correlation between SFC of IL-4 and anti-HBs (Spearman correlation coefficient = 0.538, P < 0.0001). No significant difference was found for IFN-γ SFC in two groups (10 µg group: x(-) = 1.49; 20 µg group: x(-) = 0.86; t = 1.83, P > 0.05).
The humoral and cellular immune effects of 20 µg recombinant CHO hepatitis B vaccine are better than that of the 10 µg recombinant CHO hepatitis B vaccine.20 µg recombinant CHO hepatitis B vaccine should be chosen as the adult's hepatitis B prevention vaccine.
通过随机双盲对照试验评估10μg和20μg重组中国仓鼠卵巢（CHO）细胞乙型肝炎疫苗在成人中的细胞免疫和体液免疫效果。
选取642名年龄在18 - 45岁、未接种过乙型肝炎疫苗且乙肝五项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，每组321人。分别按照0、1、6月的接种程序给予研究对象10μg和20μg重组CHO乙型肝炎疫苗。在第二次接种疫苗后1个月采集每位研究对象的血样。采用雅培化学发光检测法（I2000）检测抗-HBs水平，以评估体液免疫状态。在所有研究对象中，通过Excel随机函数随机选取153例。采集他们的血样并分离淋巴细胞，采用酶联免疫斑点法（ELISPOT）体外检测IL-4和IFN-γ水平，以评估细胞免疫状态。
10μg和20μg剂量组的抗-HBs血清转化率分别为88.8%（285/321）和95.3%（306/321），95%CI分别为85.4% - 92.2%和93.0% - 97.6%。20μg剂量组IL-4的斑点形成细胞（SFC）（x(-)=20.31）显著高于10μg剂量组（x(-)=8.19，t = 3.27，P < 0.01）。随着抗-HBs滴度的升高，IL-4的SFC也显著升高。IL-4的SFC与抗-HBs之间存在正相关（Spearman相关系数 = 0.538，P < 0.0001）。两组IFN-γ SFC无显著差异（10μg组：x(-)=1.49；20μg组：x(-)=0.86；t = 1.83，P > 0.05）。
20μg重组CHO乙型肝炎疫苗的体液免疫和细胞免疫效果优于10μg重组CHO乙型肝炎疫苗。应选择20μg重组CHO乙型肝炎疫苗作为成人预防乙型肝炎的疫苗。
