MMWR Morb Mortal Wkly Rep. 2008 Apr 18;57(15):393-8.
During clinical trials, the efficacy of vaccination with inactivated influenza vaccines for the prevention of serologically confirmed influenza infection has been estimated as high as 70%-90% among healthier adults. However, the effectiveness of annual influenza vaccination typically is lower during those influenza seasons when a suboptimal match between the vaccine strains and circulating influenza strains is observed. For example, in a 4-year randomized study of influenza vaccine among healthy persons aged 1-65 years, the predominant strain was drifted from the vaccine strain in 2 of the 4 years. Inactivated vaccine effectiveness (VE) against culture-confirmed influenza ranged from 71% to 79% when the vaccine and circulating strains were suboptimally matched to 74% to 79% when the matches were well matched. In contrast, a 2-year study of inactivated influenza vaccine among healthy adults aged 18-64 years found no measurable VE during a year when a poorly matched strain circulated, but found VE of 86% against laboratory-confirmed influenza during the following year when the vaccine and circulating strains were well matched. Although laboratory data on the antigenic characteristics of circulating influenza viruses compared with vaccine strains are available during influenza seasons, estimates of VE usually have not been made until months after the conclusion of the season. This report summarizes interim results of a 2008 case-control study to estimate the effectiveness of trivalent inactivated influenza vaccine for prevention of medically attended, laboratory-confirmed influenza during the 2007-08 influenza season, when most circulating influenza A (H3N2) and B viruses were suboptimally matched to the vaccine strains. Despite the suboptimal match between two of three vaccine strains and circulating influenza strains, overall VE in the study population during January 21-February 8, 2008, was 44%. These findings demonstrate that, in any season, assessment of the clinical effectiveness of influenza vaccines cannot be determined solely by laboratory evaluation of the degree of antigenic match between vaccine and circulation strains.
在临床试验中,对于较健康的成年人,灭活流感疫苗预防血清学确诊流感感染的效力估计高达70%-90%。然而,在观察到疫苗毒株与流行的流感毒株匹配度欠佳的流感季节,年度流感疫苗接种的效果通常较低。例如,在一项针对1-65岁健康人群的为期4年的流感疫苗随机研究中,4年中有2年主要毒株与疫苗毒株发生了抗原漂移。当疫苗毒株与流行毒株匹配度欠佳时,灭活疫苗预防培养确诊流感的效力(VE)为71%至79%,而当匹配良好时,效力为74%至79%。相比之下,一项针对18-64岁健康成年人的为期2年的灭活流感疫苗研究发现,在流行毒株匹配度差的一年中未检测到效力,但在次年疫苗毒株与流行毒株匹配良好时,预防实验室确诊流感的效力为86%。尽管在流感季节可获得关于流行流感病毒与疫苗毒株抗原特性对比的实验室数据,但效力估计通常要到季节结束数月后才进行。本报告总结了一项2008年病例对照研究的中期结果,以评估三价灭活流感疫苗在2007-2008流感季节预防就医且实验室确诊流感的效果,当时大多数流行的甲型(H3N2)和乙型流感病毒与疫苗毒株匹配度欠佳。尽管三种疫苗毒株中有两种与流行流感毒株匹配度欠佳,但在2008年1月21日至2月8日期间,研究人群的总体效力为44%。这些发现表明,在任何季节,流感疫苗临床效果的评估不能仅通过实验室评估疫苗与流行毒株之间的抗原匹配程度来确定。