不同年龄人群接种甲型H1N1流感疫苗后1个月内抗体水平的变化  

Changes of haemagglutination inhibition antibody level within one month after influenza A （ HIN1 ）vaccination

作　　者：陈庆华 张国民[2] 李燕[2] 李放军[3] 涂秋凤[4] 袁平[2] 王芙 肖奇友 王华庆[2] 张云涛 

机构地区：[1]国药中生北京微谷生物医药有限公司,101111 [2]中国疾病预防控制中心免疫规划中心,100050 [3]湖南省疾病预防控制中心 [4]江西省疾病预防控制中心 [5]国药集团中国生物技术股份有限公司

出　　处：《中华微生物学和免疫学杂志》2013年第10期744-749,共6页Chinese Journal of Microbiology and Immunology

基　　金：国家高技术研究发展计划(863计划)

摘　　要：目的：探讨不同年龄人群接种单剂15μg无佐剂甲型H1 N1流行性感冒（流感）病毒裂解疫苗（pandemic A /H1N1 influenza vaccine， A/H1N1InfV）（甲流疫苗）后1个月之内的抗体水平变化规律，为免疫方案的制定提供依据。方法采用血凝抑制试验测定受种者的血凝抑制抗体，比较每一年龄组人群在甲流疫苗接种后3、7、14、30 d的甲流抗体几何平均滴度（ geometric mean titer ，GMT）及增长倍数（ geometric mean increase ， GMI）、阳转率、保护率。结果961人接种了甲流疫苗。其中3，～11岁组在接种甲流疫苗后14 d抗体水平达到高峰，但14、30 d的保护率95％可信区间下限达不到FDA的要求；12～60岁人群在14 d达到高峰，且GMI、阳转率、保护率达到EMEA和美国FDA标准；＞60岁人群在30 d达到高峰，且GMI、阳转率、保护率达到EMEA和美国FDA标准。结论接种1剂甲流疫苗后，12～60岁人群在接种后14 d、＞60岁人群在接种后30 d均能获得有效保护；而3～11岁免前阴性人群在第14、30天达不到FDA关于保护率95％可信区间下限≥70％的要求。Objective To find the changes of haemagglutination inhibition （ HI ） antibody level against A/California/07/2009 （H1N1） within one month after pandemic A/H1N1 influenza vaccine （A/H1N1InfV） vaccination, and to provide data for drawing up immunization protocols against novel influenza . Methods The HI antibodies against A/California/07/2009 （H1N1） in sera from the inoculated subjects were tested by HI test .The geometric mean titer （ GMT） , geometric mean increase （ GMI） , seroconversion （SC） rate, seroprotection （SP） rate of HI antibodies were compared among the sera collected on day 3, 7, 14, 30 post vaccination .Results 961 participants were injected with A/H1N1InfV.In subjects aged 3 to 11 years, the antibody level peaked on day 14 post vaccination, but neither on day 14 nor on day 30, the lower bound of the two -sided 95%CI for the SP rate could fulfill the criteria of the FDA for influenza vac-cine.In subjects aged 12 to 60 years, the antibody level peaked on day 14 post vaccination and the SC rate , SP rate and GMI fulfilled the criteria of the European Medicines Agency （ EMEA） and the FDA for influenza vaccine. In subjects aged more than 60 years, the antibody level peaked on day 30 post vaccination , and the SC rate, SP rate and GMI on day 30 fulfilled the criteria of the EMEA and the FDA .Conclusion One dose A/H1N1InfV vaccination was able to induce enough protection on day 14 for subjects aged 12 to 60 years, on day 30 for subjects aged more than 60 years;however , for subjects aged 3 to 11 years who were antibody-negative at baseline , the lower bound of the two-sided 95%CI for the SP rate on day 14 and day 30 couldn′t fulfill the criteria of the FDA for influenza vaccine .

关 键 词：甲型H1N1流行性感冒疫苗 血凝抑制试验 抗体水平变化 

分 类 号：R186[医药卫生—流行病学]