摘要
目的比较成人三种乙型肝炎疫苗(Hepatitis B vaccine,HepB)—汉逊酵母HepB(HepB-HP)、CHO细胞HepB(HepB-CHO)和酿酒酵母HepB(HepB-BC)不同免疫程序的免疫原性。方法在北京市和浙江省招募20-49岁成人,分为10μgHepB-HP、10μgHepB-CHO、10μgHepB-BC、20μgHepB-BC四个接种组,每组按HepB不同基础免疫程序接种,检测接种后1-2月乙型肝炎表面抗体(HBsAb),比较抗体阳性率和几何平均浓度(GMC)。结果四个组分别纳入研究对象430名、1513名、1350名、256名。10μgHepB-HP组0-1-2月(month,m)、0-1-3m、0-1-6m、0-1-12m程序HBsAb阳性率分别为71.57%、97.37%、100%、91.58%(x^2=65.89,P<0.001),GMC(mIU/mL)分别为116.70、381.27、915.36、918.23(F=32.01,P<0.001);10μgHepB-CHO组0-1-3m、0-1-6m、0-1-12m程序HBsAb阳性率分别为83.65%、88.55%、88.17%(x^2=6.78,P=0.034),GMC(mIU/mL)分别为144.94、328.37、296.14(H=56.42,P<0.001);10μg HepB-BC组0-1-2m、0-1-3m、0-1-6m、0-1-12m程序HBsAb阳性率分别为81.34%、85.19%、87.07%、79.54%(x^2=8.63,P=0.035),GMC(mIU/mL)分别为114.41、170.65、329.21、475.13(H=71.97,P<0.001);20μgHepB-BC组0-1-2m、0-1-3m、0-1-6m程序HBsAb阳性率分别为83.02%、100%、96.46%(x^2=20.95,P<0.001),GMC(mIU/mL)分别为167.03、949.83、1688.67(F=27.01,P<0.001)。结论20-49岁成人接种HepB具有良好的免疫原性,以0-1-6m、0-1-12m程序较好。
Objective To compare immunogenicity in adults vaccinated with varying schedules,using three different hepatitis B vaccines(HepB):HepB made using a Hansenula polymorpha yeast substrate(HepB-HP),made using a CHO cell substrate(HepB-CHO),and made using a Saccharomyces cerevisiae yeast substrate(HepB-BC).Methods We recruited 20-49-year-old subjects in Beijing and Zhejiang province and divided them into four groups for vaccination with schedules that used 10μg HepB-HP,10μg HepB-CHO,10μg HepB-BC,or 20μg HepB-BC.We measured hepatitis B surface antibody(HBsAb)levels 1-2 months af ter vaccination and compared antibody positivity rates and geometric mean antibody concentrations(GMCs).Results We recruited 430,1513,1350,and 256 subjects into the four groups,respectively.HBsAb positivity rates in the 10μg HepB-HP group vaccinated using a 0-1-2-month,0-1-3-mo,0-1-6-mo,and 0-1-12-mo schedules were 71.57%,97.37%,100%,and 91.58%,respectively(x^2=65.89,P<0.001),with GMCs of 116.70,381.27,915.36,and 918.23 mIU/mL(F=32.01,P<0.001).Positivity rates for the 10μg HepB-CHO group using a 0-1-3-mo,0-1-6-mo,and 0-1-12-mo schedules were 83.65%,88.55%,and 88.17%,respectively(x^2=6.78,P=0.034),with GMCs of 144.94,328.37,and 296.14 mIU/mL(H=56.42,P<0.001).Positivity rates for the 10μg HepB-BC group using a 0-1-2-mo,0-1-3-mo,0-1-6-mo,and 0-1-12-mo schedules were 81.34%,85.19%,87.07%,and 79.54%,respectively(x^2=8.63,P=0.035),with GMCs of 114.41,170.65,329.21,and 475.13 mIU/mL(H=71.97,P<0.001).Positivity rates for the 20μg HepB-BC group using a 0-1-2-mo,0-1-3-mo,and 0-1-6-mo schedules were 83.02%,100%,and 96.46%,respectively(x^2=20.95,P<0.001),with GMCs of 167.03,949.83,and 1688.67 mIU/mL(F=27.01,P<0.001).Conclusion HepB showed good immunogenicity profiles among 20-49-year-old adults,especially using 0-1-6-month or 0-1-12-month schedules.
作者
万咏梅
王富珍
郑徽
张国民
张卫
姚军
崔富强
Wan Yongmei;Wang Fuzhen;Zheng Hui;Zhang Guomin;Zhang Wei;Yao Jun;Cui Fuqiang(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China;Beijing Municipal Center for Disease Control and Prevention,Beijing 100013,China;Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou 310009,Zhejiang,China;School of Public Health,Peking University,Beijing 100191,China)
出处
《中国疫苗和免疫》
北大核心
2020年第1期19-24,共6页
Chinese Journal of Vaccines and Immunization
基金
中国成人高危人群和社区人群乙肝疫苗优化免疫策略研究(2018ZX10721202).
关键词
乙型肝炎疫苗
免疫程序
免疫原性
Hepatitis B vaccine
Immunization schedule
Immunogenicity
作者简介
通信作者:崔富强,Email:cuifuq@126.com;第一作者:万咏梅,Email:wanyongmei76@163.com
