文章摘要
张丽,张卫,翟祥军,李艳萍,黎健,颜丙玉,李燕婷,朱凤才,黄腾,李立秋,龚晓红,崔富强,梁晓峰,徐爱强.新生儿5μg和10μg重组酵母乙型肝炎疫苗初免后抗体免疫应答比较[J].中华流行病学杂志,2012,33(3):305-308
新生儿5μg和10μg重组酵母乙型肝炎疫苗初免后抗体免疫应答比较
Comparison on the antibody response after primary immunization of 5 μg and 10 μg hepatitis B vaccine made bv recombinant DNA techniques among newborns
  
DOI:
中文关键词: 新生儿;基因重组乙型肝炎疫苗;免疫剂量;抗体应答
英文关键词: Newborns;Hepatitis B vaccine;Immunization dosage;Antibody response
基金项目:“十一五”国家科技重大专项(2008ZX10002-001,2009ZX10002-028)
作者单位
张丽 山东省疾病预防控制中心, 济南 250014 
张卫 北京市疾病预防控制中心 
翟祥军 江苏省疾病预防控制中心 
李艳萍 广西壮族自治区疾病预防控制中心 
黎健 上海市疾病预防控制中心 
颜丙玉 山东省疾病预防控制中心, 济南 250014 
李燕婷 上海市疾病预防控制中心 
朱凤才 江苏省疾病预防控制中心 
黄腾 广西壮族自治区疾病预防控制中心 
李立秋 北京市疾病预防控制中心 
龚晓红 中国疾病预防控制中心 
崔富强 中国疾病预防控制中心 
梁晓峰 中国疾病预防控制中心 
徐爱强 山东省疾病预防控制中心, 济南 250014 
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中文摘要:
      目的 比较新生儿接种5 μg和10 μg重组酵母乙型肝炎(乙肝)疫苗后抗-HBs血清应答状况.方法 以山东、江苏、上海、广西、北京5省(自治区、直辖市)为研究现场,采用5 μg重组啤酒酵母乙肝疫苗(HepB-SC)和l0μg重组汉逊酵母乙肝疫苗(HepB-HP),按照“0-1-6”免疫程序完成初免的7~ 12月龄健康婴儿.调查对象采用问卷调查并采集静脉血,应用化学发光微粒子免疫分析法(CMIA)定量检测抗-HBs.抗-HBs< 10 mIU/ml者采用CMIA检测HBsAg,HBsAg阴性者采用巢式PCR方法检测HBV-DNA.比较不同HepB初免后的抗体应答率和抗体水平,采用多因素分析方法确定HepB种类对抗体阳转率和抗体水平的影响.结果 共观察8947名5μgHepB-SC初免(5μg组)和4576名10 μg HepB-HP初免(10μg组)婴儿.5μg组无应答、低应答、正常应答和高应答率分别为1.88%、15.18%、61.42%和21.52%,10μg组分别为0.15%、2.16%、29.42%和68.26%;5 μg组无应答、低应答和正常应答率高于10μg组,高应答率低于10 μg组,各应答率之间差异均有统计学意义(P<0.01).5 μg组和10μg组初免后抗-HBs几何平均浓度分别为354.81mIU/ml(95%CI:338.84~363.08 mIU/ml)和1778.28mIU/ml(95%CI:1698.24~1819.70mIU/ml),差异有统计学意义(F=4517.17,P<0.001).多因素分析显示,排除采血月龄、性别、出生体重、早产、母亲分娩前HBsAg状态等因素影响,两种HepB初免后抗体阳性率和抗体水平的差异仍有统计学意义.结论 新生儿使用10 μg HepB-HP初免抗体应答优于5μg HepB-SC.
英文摘要:
      Objective To compare the antibody response induced by primary immunization with 5 μ g and 10 μ g hepatitis B vaccine made by recombinant DNA techniques among the newborns.Methods Healthy infants who had completed primary immunization with 5 μg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Saccharomyces (Hep-SC) or 10 μg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) were included in the study.Kids under study were 7-12 months of age and had been on 0-1-6 schedule.Standardized questionnaire was used and blood samples were collected.The titer of antibody to hepatitis B surface antigen (anti-HBs) was detected by Chemiluminescence Microparticle Imunoassay (CMIA).If anti-HBs happened to be under 10 mIU/ml,HBV DNA was further detected by nested-PCR to distinguish occult hepatitis B virus infection.Sero-conversion rate and titer of anti-HBs were compared between the two kinds of hepatitis B vaccines.Multivariate analysis was used to find the relationship between the kind of hepatitis B vaccine as well as the antibody response after debugging the other influencing factors including month-age,gender,birth-weight,premature birth and mother' s HBsAg status.Results 8947 infants vaccinated with 5 μg HepB-SC and 4576 infants vaccinated with 10 μg HepB-HP were investigated.In the 5 μg group,the rates of non-,low-,normal- and high-response were 1.88%,15.18%,61.42% and 21.52% respectively.In the 10 μg group,the corresponding rates were 0.15%,2.16%,29.42% and 68.26% respectively.The non-,low-,normal-response rates were all higher in 5 μg group than in 10 μg group (P<0.01),while the high-response rate was much higher in 10 μg group than in 5 μ g group (P<0.01).The geometric mean concentration (GMC) of anti-HBs were 354.81 mIU/ml (95% CI:338.84-363.08 mIU/ml) and 1778.28 mIU/ml (95%CI:1698.24-1819.70 mIU/ml) in the 5 μg group and 10 μg group respectively.The GMC was statistically higher in the 10 μg group than in the 5 μg group (P<0.001).The seroconversion rate and GMC were significantly different between the two groups even after debugging the other influencing factors.Conclusion Better anti-HBs response could be achieved by primary immunization with 10 μg HepB-HP than with 5 μg HepB-SC among newborns.?
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