Yang Linna, Yao Jun, Li Jing, Chen Yongdi, Jiang Zheng-Gang, Ren Jing-Jing, Xu Kai-Jin, Ruan Bing, Yang Shi-Gui, Wang Bing, Xie Tian-Sheng, Li Qian
School of Medicine, Ningbo University, Ningbo, 315211, China.
Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, Zhejiang, China.
Immunol Res. 2016 Feb;64(1):242-50. doi: 10.1007/s12026-015-8742-1.
The aim of this study was to evaluate, in adults, the immunogenicity of six hepatitis B vaccines with different doses or different manufacturers in the Chinese market and to provide evidence to support adult hepatitis B vaccination. Participants were randomly divided into six groups (I-VI). Six vaccines (4 at 10 μg/dose and 2 at 20 μg/dose) were administered intramuscularly to healthy adults at 0, 1 and 6 month intervals. All participants (16-50 years) who were negative for any hepatitis B virus serological markers were vaccinated. Anti-HBs levels were assessed 1 month and 1 year after the third vaccination. The anti-HBs seroconversion rate (anti-HBs >10 mIU/ml) was 99.4 % (99.9 % for 10 μg dose groups and 97.9 % for 20 μg dose groups) 1 month after the third vaccination, and the anti-HBs seroreversion rate was 77.0 % (75.3 and 82.6 %) 1 year after the third vaccination (n = 1036). One month after completing the vaccinations, the seroconversion rates were not significantly different (100.0, 100.0, 99.6, 100.0 %) for the four 10 μg dose and two 20 μg dose groups (99.1, 96.9 %). One year after the third vaccination, the group II positive rate was significantly higher than the other three 10 μg dose groups, and the group VI positive rate was significantly higher than the other 20 μg dose group. Groups II and VI showed a significantly higher positive rate and anti-HBs geometric mean titer (GMT) than the other groups. The anti-HBs level declined with increasing age, and the seroreversion rate and GMT decreased over time. All six vaccines had high anti-HBs seroconversion rates and good immunization effects. The 10 μg dose vaccine (Dalian High-Tech) and the 20 μg dose vaccine (GlaxoSmithKline) are recommended for adults.
本研究旨在评估中国市场上六种不同剂量或不同厂家的成人乙型肝炎疫苗的免疫原性，并为成人乙型肝炎疫苗接种提供依据。参与者被随机分为六组（I - VI）。六种疫苗（4种10μg/剂和2种20μg/剂）于0、1和6个月间隔对健康成人进行肌肉注射。所有乙肝病毒血清学标志物均为阴性的参与者（16 - 50岁）均接种疫苗。在第三次接种后1个月和1年评估抗-HBs水平。第三次接种后1个月，抗-HBs血清转化率（抗-HBs>10 mIU/ml）为99.4%（10μg剂量组为99.9%，20μg剂量组为97.9%），第三次接种后1年，抗-HBs血清逆转率为77.0%（75.3%和82.6%）（n = 1036）。完成疫苗接种1个月后，四个10μg剂量组和两个20μg剂量组的血清转化率无显著差异（100.0%、100.0%、99.6%、100.0%）（99.1%、96.9%）。第三次接种后1年，第二组阳性率显著高于其他三个10μg剂量组，第六组阳性率显著高于其他20μg剂量组。第二组和第六组的阳性率和抗-HBs几何平均滴度（GMT）显著高于其他组。抗-HBs水平随年龄增长而下降，血清逆转率和GMT随时间降低。所有六种疫苗均具有高抗-HBs血清转化率和良好的免疫效果。推荐成人使用10μg剂量疫苗（大连高科）和20μg剂量疫苗（葛兰素史克）。
