乙型肝炎疫苗初次免疫正常应答和高应答成人9年抗体持久性观察  

Antibody persistence following primary vaccination with hepatitis B vaccine among normal and high-response adults:a 9-year follow-up study

作　　者：冯艺[1] 吕静静[1] 曹传昭 孟鑫 梁晓峰 王富珍[4] 徐爱强[1] 颜丙玉[1] 张丽[1] FENG Yi;LV Jing-jing;CAO Chuan-zhao;MENG Xin;LIANG Xiao-feng;WANG Fu-zhen;XU Ai-qiang;YAN Bing-yu;ZHANG Li(Shandong Center for Disease Control and Prevention,Shandong Provincal Key Laboratory of Infection Disease Con­trol and Prevention,Ji'nan,Shandong,250014,China;不详)

机构地区：[1]山东省疾病预防控制中心山东省传染病预防控制重点实验室,山东济南250014 [2]济南市章丘区疾病预防控制中心,山东济南250200 [3]中华预防医学会,北京100021 [4]中国疾病预防控制中心免疫规划中心,北京100050

出　　处：《预防医学论坛》2021年第6期401-405,共5页Preventive Medicine Tribune

基　　金：国家科技重大专项(项目编号:2018ZX10721202);山东省泰山学者工程(项目编号:ts201511105)。

摘　　要：目的探讨乙型肝炎(乙肝)疫苗(HepB)初次免疫(初免)正常应答和高应答者成人初免后9年的抗体持久性及其影响因素。方法选择成人按照0-1-6程序不同种类HepB初免后的正常应答和高应答者[初免后1月(T1)抗-HBs≥100 mIU/ml],于初免后9年(T2)采血定量检测抗-HBs、HBsAg和抗-HBc;采用多因素非条件Logistic回归模型和多因素线性回归模型分析抗体持久性的影响因素。结果4022名随访对象中,抗-HBs阳性率由T1时的100%降为T2时的78.37%;抗-HBs几何平均浓度(GMC)由T1时的1551.83(95%CI:1488.30~1618.07)mIU/ml下降为48.16(95%CI:45.52~50.95)mIU/ml。与初免接种20μg重组酿酒酵母HepB(HepB-SC)者相比,接种20μg重组中国仓鼠卵巢细胞HepB(HepB-CHO)者T2时抗-HBs阳性率和GMC均较高,其OR(95%CI)值和b(95%CI)值分别为1.52(1.19~1.95)和0.36(0.23~0.48)。与T1时抗-HBs GMC为100~999 mIU/ml者相比,T1时抗-HBs GMC为1000~1999、2000~9999和≥10000 mIU/ml者T2时抗-HBs阳性率和GMC均较高,其OR(95%CI)值分别为4.64(3.62~5.95)、12.55(9.63~16.36)和16.82(10.61~26.66),b(95%CI)值分别为0.99(0.86~1.12)、1.87(1.76~1.97)和3.30(3.15~3.44)。T2时HBsAg阳转者9例,HBsAg阳转率为0.22%。结论成人HepB初免正常应答和高应答者初免后9年抗-HBs阳性率和GMC均下降,但多数人抗-HBs阳性率仍维持在保护水平;抗体持久性主要与初免疫苗类型和T1时抗-HBs的GMC有关。Objective To explore the 9-year antibody persistence and the risk factors associated with the persistence of antibodies against hepatitis B surface antigen(anti-HBs)after primary vaccination of hepatitis B vaccine(HepB)among normal or high-responder adults.Methods Adults who completed HepB primary vaccination at 0-,1-,6-months schedule with four different types of HepB,and induced normal or high antibody response(anti-HBs titer≥100 mIU/ml)at 1 month(T1)after the third dose were included in the study.Blood samples were collected 9 years after the primary vaccination(T2)and anti-HBs,antibody against hepatitis B core antigen(anti-HBc)and hepatitis B surface antigen(HBsAg)were tested.The risk factors associated with positive rate and GMC of anti-HBs were identified by multiple Logistic regression analysis and multifactor linear regression model analysis respectively.Results Among 4022 participants,the positive rate of anti-HBs was 100.0%at T1 and it decreased to 78.37%at T2.The corresponding GMC decreased from 1551.83(95%CI:1488.30-1618.07)mIU/ml at T1 to 48.16(95%CI:45.52-50.95)mIU/ml at T2.Compared with those vaccinated with 20μg HepB derived in Saccharomyces Cerevisiae(HepB-SC),both positive rate of anti-HBs and GMC of anti-HBs were higher in 20μg HepB derived in Chinese hamster ovary cell(HepB-CHO)group at T2,with the values of OR(95%CI)and b(95%CI)were 1.52(1.19-1.95)and 0.36(0.23-0.48),respectively.When compared with those whose anti-HBs titer was 100-999 mIU/ml at T1,the significantly higher positive rate of anti-HBs and GMC at T2 was observed in those whose anti-HBs titer was 1000-1999 mIU/ml,2000-2999 mIU/ml and≥10000 mIU/ml.The OR(95%CI)was 4.64(3.62-5.95),12.55(9.63-16.36)and 16.82(10.61-26.66)respectively,and the b(95%CI)was 0.99(0.86-1.12),1.87(1.76-1.97)and 3.30(3.15-3.44),respectively.HBsAg conversion was found in 9 persons and the conversion rate was 0.22%.Conclusion Anti-HBs GMC decreases rapidly at T2 among normal or high-responder adults after primary vaccination,while the positive rate of an

关 键 词：成年人 肝炎疫苗 乙型 免疫 抗体持久性 

分 类 号：R512.62[医药卫生—内科学]