Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Changping District, Beijing 102206, PR China.
Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, PR China.
Vaccine. 2015 Jan 3;33(2):294-7. doi: 10.1016/j.vaccine.2014.11.029. Epub 2014 Nov 29.
To evaluate the long-term efficacy of Chinese hamster ovary (CHO) cell derived hepatitis B vaccine after being used for 14-16 years in country community in Hebei province in China.
A cross-sectional investigation was carried out in 3 of 7 randomly selected rural communities in Zhengding County in 2013. The children who were born between 1997 and 1999 and were vaccinated with three doses of CHO-derived hepatitis B vaccine were eligible to participate in the study. Their sera samples were tested for HBV serological markers. For HBsAg positive children, their historical results were compared, in order to see whether these were new infections.
Among the 920 participating children, the prevalence of HBsAg, anti-HBs and anti-HBc were 0.65%, 73.15% and 1.20% respectively. The differences between birth-year groups were not significant. When compared with baseline, the vaccine efficacy was 94.2% and the anti-HBs titers of 668 children with sole anti-HBs positivity were 178.8 mI U/ml. By comparing with historical data, no new infection was found in this latest survey. Among 6 mothers of HBsAg positive children, 4 were HBsAg positive, 1 was negative and 1 was unknown.
The long-term efficacy of the CHO derived hepatitis vaccine is good and stable for 14-16 years after vaccination. A booster dose seems not necessary. Implementing mother-newborn blocking measures for newborns from HBsAg carrier mothers is urgently needed in the future.
评价中国仓鼠卵巢（CHO）细胞乙型肝炎疫苗在河北省某农村社区使用 14-16 年后的长期效果。
2013 年，在正定县随机选择的 7 个农村社区中进行了横断面调查。符合条件的研究对象为 1997 年至 1999 年出生、全程接种过 3 剂 CHO 乙型肝炎疫苗的儿童。采集血清标本，检测 HBV 血清学标志物。对 HBsAg 阳性儿童进行历史结果比较，以确定是否为新感染。
920 名儿童中 HBsAg、抗-HBs 和抗-HBc 的流行率分别为 0.65%、73.15%和 1.20%。不同出生年份组间差异无统计学意义。与基线相比，疫苗保护效力为 94.2%，668 名单纯抗-HBs 阳性儿童的抗-HBs 滴度为 178.8 mIU/ml。与历史数据比较，未发现新的感染病例。6 名 HBsAg 阳性儿童的母亲中，4 名 HBsAg 阳性，1 名 HBsAg 阴性，1 名 HBsAg 状态未知。
CHO 乙型肝炎疫苗接种后 14-16 年的长期效果良好且稳定，无需加强免疫。今后应加强对 HBsAg 阳性母亲所生新生儿的母婴阻断措施。
