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预防医学  2017, Vol. 29 Issue (9): 869-873    DOI: 10.19485/j.cnki.issn1007-0931.2017.09.002
  论 著 本期目录 | 过刊浏览 | 高级检索 |
16岁及以上人群接种60 μg重组乙肝疫苗安全性及免疫原性研究
曾滢1, 陈鲁粤1, 杨忠华1, 汪婷婷1, 梁晓峰2, 王富珍2, 崔富强2, 杜伟民1, 蒋征刚3, 姚军3
1.深圳康泰生物制品股份有限公司,广东 深圳 518057;
2.中国疾病预防控制中心;
3.浙江省疾病预防控制中心
Safety and immunogenicity evaluation of 60 μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae)in population aged 16 and above
ZENG Ying, CHEN Lu-yue, YANG Zhong-hua, WANG Ting-ting, LIANG Xiao-feng, WANG Fu-zhen, CUI Fu-qiang, DU Wei-min, JIANG Zheng-gang, YAO Jun
Shenzhen Kangtai Biological Products Co.,Ltd.,Shenzhen,Guangdong,518057,China
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摘要 目的 评价≥16岁正常人群接种60 μg 重组乙型病毒性肝炎(乙肝)疫苗(酿酒酵母)的安全性和免疫原性。方法 对纳入的4 345名(包括3 415名初免人群和930名常规免疫无应答人群)≥16岁正常人群接种60 μg重组乙肝疫苗(酿酒酵母),观察所有受试者疫苗接种后0~28 d内出现的不良反应;检测930名常规免疫无应答人群接种前和接种后1个月后乙肝病毒表面抗体(抗-HBs),分析抗体阳转率和几何平均滴度(GMT)。结果 4 345人均完成接种,712人发生不良反应,不良反应发生率为16.39%,其中局部不良反应657人,发生率为15.12%;全身不良反应176人,发生率为4.05%,以1级不良反应为主,未见有临床意义的严重不良事件。930名常规接种无应答者抗-HBs阳转率为87.03%(718/825),其中应答反应活跃者占76.74%(551/718),抗-HBs水平为479.28 mIU / mL。不同性别和年龄组间抗-HBs阳转率差异无统计学意义(P>0.05)。女性抗-HBs GMT高于男性(P<0.05),不同年龄组抗-HBs GMT差异无统计学意义(P>0.05)。结论 60 μg重组乙肝疫苗(酿酒酵母)用于≥16岁正常人群具有良好的安全性;对乙肝疫苗基础免疫失败人群接种,同样能够产生良好的免疫效果。
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曾滢
陈鲁粤
杨忠华
汪婷婷
梁晓峰
王富珍
崔富强
杜伟民
蒋征刚
姚军
关键词 重组乙型病毒性肝炎疫苗(酿酒酵母)无应答安全性免疫原性    
AbstractObjective To evaluate the safety of 60 μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae)in healthy population over 16 years old and immunogenicity in non-responders. Methods A total of 4 345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine, including 3 415 participants who have never been vaccined before and 930 non-responders. All participants were monitored for any adverse events occurring within 30 min after each injection and instructed to record selected injection-site reactions and systemic reactions on the day of vaccination and the subsequent 28 days. Blood samples were collected from non-responders at pre-vaccination and one month after vaccination,in order to determine anti-HBs levels,positive rates of anti-HBs and the mean geometric titre(GMT)of anti-HBs. Results Among 4 345 vaccinated participants,16.39 % of them reported at least one injection-site or systemic adverse reaction. The most common injection-site and systemic adverse reactions were Grade 1 adverse reactions with the incidence of 15.12 %(657/4 345)and 4.05%(176/4 345)respectively. No serious adverse events were observed. Among 930 non-responders,the positive rate of anti-HBs was 87.03 % with active responder of 76.74 %(551 / 718)and the GMT of anti-HBs was 479.28 mIU / ml. The positive rate of anti-HBs was not associated with gender or age(P>0.05). The GMT of anti-HBs demonstrated significant differences between female and male (560.66 mIU / mL VS. 404.91 mIU / mL,P<0.05),but there was no significant differences in different age groups(P>0.05). Conclusion 60 μg recombinant hepatitis B vaccine was safe for healthy adults above 16 years and had good immunity efficacy among non-responders who had no or low response to standard immunization regimen of hepatitis B vaccine.
Key wordsRecombinant hepatitis B vaccine(Saccharomyces Cerecisiae)    Non-responders    Safety    Immunogenicity
收稿日期: 2017-01-05      出版日期: 2017-10-12
ZTFLH:  R512.6+2  
基金资助:国家科技重大专项(2012ZX10002001-006)
通信作者: 姚军,E-mail:jyao@cdc.zj.cn   
作者简介: 曾滢,硕士,教授级高级工程师,主要从事疫苗研发工作
引用本文:   
曾滢, 陈鲁粤, 杨忠华, 汪婷婷, 梁晓峰, 王富珍, 崔富强, 杜伟民, 蒋征刚, 姚军. 16岁及以上人群接种60 μg重组乙肝疫苗安全性及免疫原性研究[J]. 预防医学, 2017, 29(9): 869-873.
ZENG Ying, CHEN Lu-yue, YANG Zhong-hua, WANG Ting-ting, LIANG Xiao-feng, WANG Fu-zhen, CUI Fu-qiang, DU Wei-min, JIANG Zheng-gang, YAO Jun. Safety and immunogenicity evaluation of 60 μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae)in population aged 16 and above. Preventive Medicine, 2017, 29(9): 869-873.
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http://www.zjyfyxzz.com/CN/10.19485/j.cnki.issn1007-0931.2017.09.002      或      http://www.zjyfyxzz.com/CN/Y2017/V29/I9/869
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