中华微生物学和免疫学杂志
中華微生物學和免疫學雜誌
중화미생물학화면역학잡지
CHINESE JOURNAL OF MICROBIOLOGY AND IMMUNOLOGY
2013年
10期
744-749
,共6页
陈庆华%张国民%李燕%李放军%涂秋凤%袁平%王芙%肖奇友%王华庆%张云涛
陳慶華%張國民%李燕%李放軍%塗鞦鳳%袁平%王芙%肖奇友%王華慶%張雲濤
진경화%장국민%리연%리방군%도추봉%원평%왕부%초기우%왕화경%장운도
甲型H1 N1流行性感冒疫苗%血凝抑制试验%抗体水平变化
甲型H1 N1流行性感冒疫苗%血凝抑製試驗%抗體水平變化
갑형H1 N1류행성감모역묘%혈응억제시험%항체수평변화
Pandemic A/H1N1 influenza vaccine%Hemagglutination inhibition test%Changes of HI antibody level
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。
目的：探討不同年齡人群接種單劑15μg無佐劑甲型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）後1箇月之內的抗體水平變化規律，為免疫方案的製定提供依據。方法採用血凝抑製試驗測定受種者的血凝抑製抗體，比較每一年齡組人群在甲流疫苗接種後3、7、14、30 d的甲流抗體幾何平均滴度（ geometric mean titer ，GMT）及增長倍數（ geometric mean increase ， GMI）、暘轉率、保護率。結果961人接種瞭甲流疫苗。其中3，～11歲組在接種甲流疫苗後14 d抗體水平達到高峰，但14、30 d的保護率95％可信區間下限達不到FDA的要求；12～60歲人群在14 d達到高峰，且GMI、暘轉率、保護率達到EMEA和美國FDA標準；＞60歲人群在30 d達到高峰，且GMI、暘轉率、保護率達到EMEA和美國FDA標準。結論接種1劑甲流疫苗後，12～60歲人群在接種後14 d、＞60歲人群在接種後30 d均能穫得有效保護；而3～11歲免前陰性人群在第14、30天達不到FDA關于保護率95％可信區間下限≥70％的要求。
목적：탐토불동년령인군접충단제15μg무좌제갑형H1 N1류행성감모（류감）병독렬해역묘（pandemic A /H1N1 influenza vaccine， A/H1N1InfV）（갑류역묘）후1개월지내적항체수평변화규률，위면역방안적제정제공의거。방법채용혈응억제시험측정수충자적혈응억제항체，비교매일년령조인군재갑류역묘접충후3、7、14、30 d적갑류항체궤하평균적도（ geometric mean titer ，GMT）급증장배수（ geometric mean increase ， GMI）、양전솔、보호솔。결과961인접충료갑류역묘。기중3，～11세조재접충갑류역묘후14 d항체수평체도고봉，단14、30 d적보호솔95％가신구간하한체불도FDA적요구；12～60세인군재14 d체도고봉，차GMI、양전솔、보호솔체도EMEA화미국FDA표준；＞60세인군재30 d체도고봉，차GMI、양전솔、보호솔체도EMEA화미국FDA표준。결론접충1제갑류역묘후，12～60세인군재접충후14 d、＞60세인군재접충후30 d균능획득유효보호；이3～11세면전음성인군재제14、30천체불도FDA관우보호솔95％가신구간하한≥70％적요구。
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 .
