婴儿国产和进口重组酵母乙型肝炎疫苗基础免疫序贯接种后2年乙型肝炎表面抗体血清流行率  

Two-year hepatitis B antibody sero-prevalence following sequential primary vaccination with domestic and imported recombinant yeast-based hepatitis B vaccines

作　　者：徐娜妮[1] 胡小炜[1] 郑琳[1] 范从娟 温晓群 Zheng Lin;Fan Congjuan;Wen Xiaoqun(Xihu District Center for Disease Control and Prevention,Hangzhou 310030,Zhejiang,China;Wenxin Street Community Health Service Center of Xihu District,Hangzhou 310012,Zhejiang,China)

机构地区：[1]杭州市西湖区疾病预防控制中心,浙江杭州310030 [2]杭州市西湖区文新街道社区卫生服务中心,浙江杭州310012

出　　处：《中国疫苗和免疫》2021年第5期501-503,508,共4页Chinese Journal of Vaccines and Immunization

基　　金：中国肝炎防治基金会中国乙肝防控科研基金资助项目(YGFK20190070)。

摘　　要：目的评价国产和进口重组酵母乙型肝炎疫苗(Hepatitis B vaccine,HepB)在儿童基础免疫序贯接种后2年的乙型肝炎表面抗体(Hepatitis B surface antibody,HBsAb)血清流行率。方法采用回顾性队列研究,在杭州市西湖区选取2015-2017年出生、在1岁内按照“0-1-6月”免疫程序完成1剂次国产10μg重组汉逊酵母HepB与2剂次进口10μg重组啤酒酵母HepB序贯接种(试验组)或3剂次国产10μg重组汉逊酵母HepB接种(对照组)的儿童,采集全程接种后2年血清标本,使用化学发光法检测HBsAb,比较两组儿童HBsAb阳性率和几何平均浓度(Geometric mean concentration,GMC)。结果试验组、对照组分别纳入390名和1133名儿童,完成HepB接种后2年的HBsAb阳性率(95%CI)分别为96.92%(95.20%-98.64%)、95.32%(94.09%-96.55%);GMC(95%CI)分别为167.57(144.24-194.67)mIU/mL、132.86(121.67-145.08)mIU/mL。结论婴儿国产重组汉逊酵母HepB与进口重组啤酒酵母HepB基础免疫序贯接种后2年具有良好的免疫力。Objective To evaluate hepatitis B surface antibody(HBsAb)sero-prevalence at 2 years of age of following sequential primary vaccination with domestic and imported recombinant yeast-based hepatitis B vaccines(HepB).Methods We conducted a retrospective cohort study among children born during 2015-2017 in Xihu district of Hangzhou city who had received either one dose of 10μg domestic HepB followed by 2 doses of 10μg imported HepB(the study group)or 3 doses of 10μg domestic HepB(the control group)during the first year of life in 0-1-6-month schedules.We collected sera 2 years after HepB series completion and tested for HBsAb using a chemiluminescence microparticle immunoassay;we compared the two groups on sero-positivity and geometric mean concentration(GMC).Results Among the 390 subjects in the study group and the 1133 subjects in the control group,HBsAb sero-positivity rates(95%CI)2 years after HepB series completion were 96.92%(95.20%-98.64%)and 95.32%(94.09%-96.55%),respectively;GMCs(95%CI)were 167.57(144.24-194.67)mIU/mL and 132.86(121.67-145.08)mIU/mL.Conclusions Sequential primary vaccination with domestic and imported recombinant yeast-based HepB showed a good immunity profile 2 years after infant vaccination.

关 键 词：乙型肝炎疫苗 乙型肝炎表面抗体 血清流行率 婴儿 

分 类 号：R186[医药卫生—流行病学]