摘要
目的分析乙型肝炎疫苗(HepB)初次免疫正常及高应答婴儿初次免疫后10年的抗体持久性及其影响因素。方法于2009年8—9月,以山东省济南、潍坊、烟台和威海市为研究现场,按照随机整群抽样方法,抽取1838名按照"0-1-6"程序完成5μg重组酵母HepB初次免疫的正常应答及高应答[乙型肝炎表面抗体(抗-HBs)≥100 mIU/ml]的7~12月龄婴儿为研究对象。基线调查时(T_(0)),采集研究对象静脉血3 ml,采用化学发光微粒子免疫分析法(CMIA)检测乙肝表面抗体(抗-HBs)、乙肝表面抗原(HBsAg)和乙肝核心抗体(抗-HBc),同时采用自行设计的调查问卷收集婴儿的月龄、性别、出生体重、是否早产、出生胎次、分娩地点以及母亲HBV感染状况等信息。分别于2014年6—7月(随访5年)、2019年6—7月(随访10年)(T_(1)),采集对象静脉血2 ml,采用CMIA方法检测抗-HBs、抗HBc,对抗-HBs<10 mIU/ml者采用CMIA法检测HBsAg。采用多因素非条件logistic和线性回归模型分析T_(1)时抗-HBs阳性率和几何平均浓度(GMC)的影响因素。结果1838名研究对象进行10年随访,共随访到1359名对象,随访率为73.94%(1359/1838);其中,男童占51.15%(625名)。研究对象抗-HBs阳性率由T_(0)时的100.00%降为T_(1)时的53.44%(95%CI:50.59%~56.26%),降幅为46.56%,年均递减率为6.07%;研究对象抗-HBs GMC由T_(0)时的607.89(95%CI:579.01~642.62)mIU/ml降为T_(1)时的16.44(95%CI:15.06~18.00)mIU/ml,降幅达97.29%,年均递减率为30.30%。多因素logistic回归模型分析结果显示,与及时接种首针HepB者相比,未及时接种首针HepB者的T_(1)时抗-HBs阳性率较低,OR(95%CI)值为0.25(0.07~0.71);与T_(0)时GMC<1000 mIU/ml者相比,GMC≥1000 mIU/ml者的T_(1)时抗-HBs阳性率较高,OR(95%CI)值为2.29(1.76~2.97)。多因素线性回归模型分析结果显示,与及时接种首针HepB者相比,未及时接种首针HepB者的T_(1)时抗-HBs GMC较低,β(95%CI)值为-0.50(-1.24~0.24);与T_(0)时GMC<1000 mIU/ml者相比,GM
Objective Assess the 10-year Immune persistence and the predictors after primary vaccination hepatitis B vaccine(HepB)among normal and high-responder infants.Methods A total of 1838 Infants of 7-12 months old located in Jinan,Weifang,Yantai and Weihai of Shandong Province who were induced normal or high antibody response(anti-HBs titer≥100 mIU/ml)after primary vaccination(three dose with 0-1-6 procedure)with 5μg recombinant HepB among newborns were included in the study,in 2009.3 ml of venous blood samples were collected at baseline survey(T_(0))and antibodies against hepatitis B surface antigen(anti-HBs),antibody against hepatitis B core antigen(anti-HBc)and hepatitis B surface antigen(HBsAg)were detected using chemiluminescence microparticle immunoassay(CMIA)method.A self-designed questionnaire was used to collect information including the infant′s age,sex,birth weight,premature birth,birth number,delivery location and mother′s HBV infection status.In 2014(followed up for 5 years)and in 2019(followed up for 10 years)(T_(1)),2 ml of venous blood samples were collected.Anti HBS and anti HBC were detected by CMIA method.Those with anti HBS<10 mIU/ml were detected by CMIA method.Multivariate unconditional logistic and linear regression models were used to analyze the influencing factors of anti-HBs positive rate and geometric mean concentration(GMC)at T_(1).Results After 10 years follow-up,73.94%of the subjects(1359/1835)finished the follow-up.51.15%of the subjects,a total of 625 were boys.The positive rate of anti-HBs was 100%at T_(0) and decreased to 53.44%(95%CI:50.59%-56.26%)at T_(1).The average annual decline rate of anti-HBs positive rate from T_(0) to T_(1) was 6.07%.The GMC of anti-HBs decreased from 607.89(95%CI:579.01-642.62)mIU/ml to 16.44(95%CI:15.06-18.00)mIU/ml.The average annual decline rate of anti-HBs GMC in 10-year follow-up was 30.30%.Multivariate logistic analysis showed that the positive rate of anti-HBs at T_(1) was lower in those who did not vaccinate the first dose in time(OR=0.25,95%
作者
孟鑫
吕静静
冯艺
窦璇
赵雪
梁晓峰
王富珍
徐爱强
颜丙玉
张丽
Meng Xin;Lyu Jingjing;Feng Yi;Dou Xuan;Zhao Xue;Liang Xiaofeng;Wang Fuzhen;Xu Aiqiang;Yan Bingyu;Zhang Li(Expanded Program Immunizatin Division,Shandong Provincial Center for Disease Control and Prevention,Institute for Preventive Medicine of Shandong University,Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention,Jinan 250014,China;School of Pubic Health,Cheeloo College of Medicine,Shandong University,Jinan 250012,China;Chinese Preventive Medicine Association,Beijing 100021,China;Center for National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)
出处
《中华预防医学杂志》
CAS
CSCD
北大核心
2022年第6期794-799,共6页
Chinese Journal of Preventive Medicine
基金
国家科技重大专项(2018ZX10721202)
山东省泰山学者工程(ts201511105)。
