US Influenza Vaccine Effectiveness Network

项目摘要： 接种流感疫苗是预防流感病毒感染及其更严重的最有效手段 并发症由于流感病毒的性质不断改变， 疫苗成分和每年接种疫苗是疫苗保护所必需的。有必要 疫苗有效性（VE）的年度评估，每年可能会有所不同。这些估计是至关重要的 告知医学界，保持公众对疫苗的信心，并确定病毒的效果 保护漂移。评估VE的现代研究设计需要实验室确认流感感染， 疫苗接种的敏感和具体措施，以及使用病例测试阴性设计来控制 接种疫苗和未接种疫苗的患者之间的就医行为差异。我们建议使用 这些方法估计流感VE在预防流感相关的门诊护理访问在两个健康 密歇根州的系统，自2008年以来，我们一直在进行VE的年度评估。我们会进行 在成人和儿科门诊诊所进行监测，我们将招募寻求急性 符合标准病例定义的呼吸道感染。将报告和记录疫苗接种状态， 并考虑实验室确认的流感结果，以估计VE在预防流感中的作用- 相关的医疗保健访问。分析将使用病例测试阴性设计;那些测试阳性的 流感将作为病例，检测阴性的将作为对照。VE的修饰和混杂因素，如年龄， 健康状况、高危健康状况、教育程度、从发病到标本采集的时间，以及 日历时间将被评估。我们还将估计以人口为基础的医疗照顾的发病率 流感，并将确定由于呼吸道合胞病毒（RSV）和其他呼吸道病毒感染， 研究的后期。我们将试行监测流感病毒抗药性的方法， 抗病毒药物，可以为未来潜在的流感大流行进行类似的研究提供信息。在 除了我们建议的门诊流感监测和VE评估外，我们还建议 继续我们的分析，流感VE和流感抗体的发展之间的前瞻性 2010年以来一直在跟踪有子女家庭的队列。该队列将用于 进行VE的补充分析，以预防任何严重程度的流感， 通过持续的积极监测。对这一群体的家庭进行了多年的跟踪调查， 从而能够精确评估重复接种。我们目前的招生策略将得到加强， 有针对性地招收有3岁以下儿童的家庭。将从成人中采集血液样本 和儿童每年两次;第三次血液标本将从儿童< 3岁后4周收集 预防针拟议的工作将使我们既定的、协调的、多方面的 在门诊和社区环境中评估流感病毒VE和抗体的产生。

Project Summary Abstract: Influenza vaccination is the most effective means of preventing influenza virus infection and its more severe complications. Due to the changing nature of influenza viruses, active surveillance alongside regular updating of vaccine components and annual vaccination are necessary for vaccine protection. There is a need for annual evaluation of vaccine effectiveness (VE), which may vary from year to year. These estimates are critical to inform the medical community, maintain public confidence in the vaccine, and determine the effect of virus drift on protection. Modern study designs to assess VE require laboratory confirmation of influenza infection, sensitive and specific measures of vaccine receipt, and the use of a case test-negative design to control for differences in healthcare-seeking behavior between vaccinated and unvaccinated patients. We propose to use these methods to estimate influenza VE in preventing influenza-associated ambulatory care visits in two health systems in Michigan, where we have been conducting annual assessments of VE since 2008. We will conduct surveillance at adult and pediatric outpatient clinics, and we will enroll patients seeking care for acute respiratory infections meeting a standard case definition. Vaccination status will be reported and documented, and considered with laboratory-confirmed influenza outcomes to estimate VE in preventing influenza- associated health care visits. Analyses will use the case test-negative design; those testing positive for influenza will be cases, those testing negative will be controls. Modifiers and confounders of VE such as age, health status, high-risk health conditions, education, time from illness onset to specimen collection, and calendar time will be assessed. We will also estimate the population-based incidence of medically-attended influenza and will identify infections due to respiratory syncytial virus (RSV) and other respiratory viruses in later years of the study. We will pilot methods to monitor the development of influenza virus resistance to antiviral medications which could inform similar studies carried out in a potential future influenza pandemic. In addition to our proposed influenza surveillance and VE assessment in the outpatient setting, we propose to continue our analyses of influenza VE and development of influenza antibodies among a prospectively followed cohort of households with children which has been in place since 2010. This cohort will be used to carry out complementary analyses of VE in preventing influenza illnesses of any severity which will be identified through ongoing active surveillance. Households in this cohort are followed for multiple years, enabling precise evaluations of repeated vaccination. Our current enrollment strategies will be augmented with targeted enrollment of households with children under age 3. Blood specimens will be collected from adults and children twice yearly; a third blood specimen will be collected from children < 3 years old 4 weeks after vaccination. The proposed work will enable the continuation of our established, coordinated, multi-faceted evaluation of influenza VE and development of antibodies in both ambulatory and community settings.