重组乙肝疫苗在部队人群中免疫效果观察

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摘要目的调查军队人群乙肝血清抗体的本底水平,观察重组乙肝疫苗(20 μg/ml)的免疫效果,为探索适合新兵、新学员的乙肝免疫程序打下基础。方法通过血清抗体初筛确定10 102名新兵为观察对象,免疫前抗-HBs检测结果为弱阳性者按照0、1程序接种2针乙肝疫苗,分别在2针后测抗-HBs水平;免疫前抗-HBs检测结果为阴性者按照0、1、6程序接种3针乙肝疫苗,分别在第2、3针后测抗-HBs水平;比较不同针次后的抗-HBs阳转率、抗体几何平均滴度(GMT)水平,阴性者的高应答反应。结果免疫前10 102名观察对象的血清抗-HBs检测中弱阳性者为1090人(10.8%),阴性者为3251人(32.2%)。弱阳性者接种乙肝疫苗1、2针后阳转率分别为90.0%、97.8%,GMT分别为5007.75 mIU/ml和6295.77 mIU/ml; 接种2针阳转率明显优于接种1针(P<0.01)。阴性者接种乙肝疫苗2、3针后采血,阳转率分别为86.1%、98.7%,高应答反应率分别为56.4%、87.5%,GMT分别为1214.41 mIU/ml和2231.57 mIU/ml; 接种3针阳转率明显优于接种2针(P<0.01)。本次试验期间,未收到三级(含)及以上不良反应报告。结论有必要在免疫前先进行抗-HBs检测,再选用重组乙肝疫苗(20 μg/ml)进行科学接种;血清抗-HBs弱阳性对象选用0、1两针接种程序,血清抗-HBs阴性对象选用0、1、6三针接种程序,均可获得明显的免疫效果。

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关键词 ：成人, 乙肝疫苗, 免疫策略

Abstract：Objective To investigate the level of anti-HBs and the immunogenicity of recombinant Hepatitis B vaccine, so as to seek for proper immune procedure in healthy soldier populations in China.Methods The anti-HBs weakly positive subjects were immunized at months 0 and 1. The anti-HBs negative subjects were immunized at months 0,1 and 6.Serum samples were collected before and after immunization.Adverse reaction data were collected within one month after vaccination. Results A total of 10102 healthy adult volunteers were enrolled in this study. There were 5761 anti-HBs positive subjects (57.7%), 1090 anti-HBs weakly positive subjects (10.8%) and 3251 anti-HBs negative subjects (32.2%). The positive conversion rate of anti-HBs weakly positive subjects was 90.0% after the first dose,and was 97.8% after the second dose. The positive conversion rate after the second dose was significantly higher than that after the first dose (P<0.01).The geometric mean titer (GMT) was 5007.75 mIU/ml after the first dose,and 6295.77 mIU/ml after the second dose.The positive conversion rate in anti-HBs negative subjects was 86.1% after the second dose,and 97.8% after the third dose. The positive conversion rate after the third dose was significantly higher than that after the second dose (P<0.01).The GMT was 1214.41 mIU/ml after the second dose,and was 2231.57 mIU/ml after the third dose.There were 1294 high-responders (56.4%) after the second dose, and 1635 high-responders (87.5%) after the third dose. No severe adverse events or unexpected events were reported during the follow-up.Conclusion It is effective to conduct the booster immunization for anti-HBs weakly positive adult with two dosages and for anti-HBs negative adult with three dosages.

Key words： Adult Hepatitis B Vaccine Immunization

出版日期: 2016-08-30

引用本文:

曹玮民, 唐玥, 常国辉, 孙走南, 刘京梅, 杨益, 苏文莉, 李瑾慧, 刘明海, 胡芸, 徐力, 徐静, 陈玉广. 重组乙肝疫苗在部队人群中免疫效果观察[J]. 解放军预防医学杂志, 2016, 34(3): 327-330.
CAO Weimin, TANG Yue, CHANG Guohui, SUN Zounan, LIU Jingmei, YANG Yi, SU Wenli,LI Jinhui, LIU Minghai, HU Yun, XU Li, XU Jing, CHEN Yuguang. The Immunity Effect of Hepatitis B Vaccine in the Military Population. Journal of Preventive Medicine of Chinese People's Liberation Army, 2016, 34(3): 327-330.

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http://manu37.magtech.com.cn/Jwk_jsyxkx/jfj/CN/ 或 http://manu37.magtech.com.cn/Jwk_jsyxkx/jfj/CN/Y2016/V34/I3/327

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