Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
Vaccine. 2012 Oct 19;30(47):6623-7. doi: 10.1016/j.vaccine.2012.08.067. Epub 2012 Sep 7.
To evaluate the long-term efficacy and duration of yeast-derived recombinant hepatitis B vaccine in hepatitis B virus (HBV)-endemic areas.
A cross-sectional investigation was carried out in five HBV-endemic areas. Children who were born between 1997 and 2008 and vaccinated with yeast-derived recombinant hepatitis B vaccine were selected. Serum samples were taken to test HBV infection markers by microparticle enzyme immunoassay, and the results were compared to those before vaccination.
7066 subjects were enrolled. The average adjusted hepatitis B surface antigen (HBsAg) prevalence was 1.02%. HBV core antibody (anti-HBc) prevalence was 3.54%. The overall percentage of HBsAg(-)&Anti-HBc(-)&Anti-HBs(+) was 61.34%. With time after immunization, the percentage annually decreases from 86.11% in 2008 to 49.80% in 1997. Geometric mean concentration (GMC) of anti-HBs decreased significantly annually. The portion of GMC=100-999.9 mIU/ml was 48.0% in 2008, and decreased to 16.7% in 1997.
HBsAg prevalence decreased dramatically. This shows that the yeast-derived recombinant hepatitis B vaccine is effective and stable after being used for 12 years in HBV-endemic areas. It is not suggested to carry out booster immunization.
评估乙型肝炎病毒（HBV）流行地区酵母源性重组乙型肝炎疫苗的长期疗效和持续时间。
在五个 HBV 流行地区进行横断面调查。选择 1997 年至 2008 年间出生并接种酵母源性重组乙型肝炎疫苗的儿童。采集血清样本，采用微粒子酶免疫分析法检测 HBV 感染标志物，并与接种前的结果进行比较。
共纳入 7066 例受试者。平均调整后的乙型肝炎表面抗原（HBsAg）流行率为 1.02%。HBV 核心抗体（抗-HBc）流行率为 3.54%。HBsAg（-）&抗-HBc（-）&抗-HBs（+）的总比例为 61.34%。随着免疫后时间的推移，每年的比例从 2008 年的 86.11%下降到 1997 年的 49.80%。抗-HBs 的几何平均浓度（GMC）每年显著下降。GMC=100-999.9 mIU/ml 的比例在 2008 年为 48.0%，在 1997 年下降至 16.7%。
HBsAg 的流行率显著下降。这表明在 HBV 流行地区使用酵母源性重组乙型肝炎疫苗 12 年后，该疫苗具有良好的效果和稳定性，不建议进行加强免疫。
