Beijing Center for Disease Control and Prevention, Beijing 100013, China.
Vaccine. 2011 Aug 26;29(37):6276-82. doi: 10.1016/j.vaccine.2011.06.045. Epub 2011 Jun 29.
To compare the immune responses of the 10 μg and 20 μg doses of CHO hepatitis B vaccine on adults.
Adults aged 18-45 years who gave a history of never having received hepatitis B vaccine and lacked serologic evidence of infection to hepatitis B virus (HBV) infection or previous vaccination were enrolled into the study. A total of 642 eligible participants were randomized to receive 3 doses of either the 10 μg or the 20 μg formulation of CHO hepatitis B vaccine in a 0-1-6 month schedule. Each study subject had a serologic specimen collected one month following the third vaccine dose that was tested for markers of HBV infection and anti-HBs by Abbott I2000. Persons who tested negative for anti-HBs negative persons were tested for HBV DNA. Logistic regression was used to identify factors associated with antibody response. Among the participants, 153 subjects had their lymphocytes cultivated and tested for cytokine production. Enzyme-linked immunospot (ELISPOT) was used to test spot numbers of IL-4, IFN-γ which produced by lymphocyte.
The anti-HBs seroconversion rate was 88.8% (95% CI: 85.4-92.2%) and 95.3% (95% CI: 93.0-97.6%), respectively in 10 μg and 20 μg group. Geometric mean titers (GMT) were 173.42 mIU/ml and 585.51 mIU/ml, respectively in 10 μg and 20 μg groups. Multivariate analysis demonstrated that diabetes, spouse is hepatitis B virus infector, older age and receipt of the 10 μg dose were all negatively associated with antibody response (P<.05). Cellular immunity results showed: IL-4 immunity spot numbers in 20 μg group was higher than 10 μg group. With anti-HBs increased, the IL-4 immunity spot numbers increased significantly which had significant positive correlation (Spearman coefficient=0.538, P<0.0001). IFN-γ spot numbers had no statistical significant between the two groups.
The humoral immunity and cytokines response among the group that received the 20 μg CHO hepatitis B vaccine dose was superior compared to the group that received the 10 μg dose. The 20 μg dose of CHO hepatitis B vaccine should be prioritized for adult vaccination programs in China.
比较 10μg 和 20μg 剂量 CHO 乙型肝炎疫苗在成人中的免疫应答。
纳入既往未接种过乙型肝炎疫苗且无乙型肝炎病毒（HBV）感染或既往接种史的 18-45 岁成年人。642 名合格参与者按 0-1-6 月方案随机分为两组，分别接受 3 剂 10μg 或 20μgCHO 乙型肝炎疫苗。每组研究对象在第三剂疫苗接种后一个月采集血清标本，采用雅培 I2000 检测 HBV 感染和抗-HBs 标志物。抗-HBs 阴性者检测 HBV DNA。采用 logistic 回归分析确定与抗体应答相关的因素。其中 153 例受试者进行淋巴细胞培养和细胞因子检测。酶联免疫斑点法（ELISPOT）检测 IL-4、IFN-γ 产生的淋巴细胞斑点数。
10μg 和 20μg 组抗-HBs 血清转换率分别为 88.8%（95%CI：85.4-92.2%）和 95.3%（95%CI：93.0-97.6%）。GMT 分别为 173.42 mIU/ml 和 585.51 mIU/ml。多因素分析显示，糖尿病、配偶为 HBV 感染者、年龄较大和接种 10μg 剂量均与抗体应答呈负相关（P<.05）。细胞免疫结果显示：20μg 组 IL-4 免疫斑点数高于 10μg 组。抗-HBs 增加时，IL-4 免疫斑点数显著增加，呈显著正相关（Spearman 系数=0.538，P<0.0001）。两组间 IFN-γ 斑点数无统计学差异。
接种 20μgCHO 乙型肝炎疫苗组的体液免疫和细胞因子反应优于接种 10μg 剂量组。中国成人乙型肝炎疫苗接种计划应优先考虑 20μgCHO 乙型肝炎疫苗。
