US Influenza Vaccine Effectiveness Network

项目摘要摘要： 接种流感疫苗是预防流感病毒感染最有效的手段，而且更严重 并发症。由于流感病毒的性质不断变化，积极监测并定期更新 疫苗成分和每年接种疫苗对于疫苗保护是必要的。有必要 疫苗有效性的年度评估(VE)，每年可能有所不同。这些估计至关重要。 告知医学界，维持公众对疫苗的信心，并确定病毒的效果 随波逐流的保护。评估VE的现代研究设计要求实验室确认流感感染， 敏感和具体的疫苗接种措施，并使用病例试验阴性设计来控制 接种疫苗与未接种疫苗患者就医行为的差异。我们建议使用 这些方法在预防流感相关门诊就诊中评估流感VE在两个健康人中的作用 自2008年以来，我们一直在密歇根州对VE进行年度评估。我们将进行 在成人和儿科门诊进行监测，我们将招募寻求急性呼吸道疾病治疗的患者。 符合标准病例定义的呼吸道感染。疫苗接种情况将被报告和记录， 并结合实验室确认的流感结果来评估VE在预防流感方面的作用- 相关的医疗服务访问。分析将使用案例测试-阴性设计；那些测试为阳性的 将出现流感病例，那些检测结果为阴性的将进行控制。VE的修饰者和混杂因素，如年龄， 健康状况、高危健康状况、教育程度、从发病到样本采集的时间，以及 将评估日历时间。我们还将估计以人群为基础的接受医疗护理的发病率 流感，并将确定由呼吸道合胞病毒(RSV)和其他呼吸道病毒在 这项研究的后几年。我们将试行流感病毒耐药性监测方法 抗病毒药物，这可能为未来可能发生的流感大流行中进行的类似研究提供信息。在……里面 除了我们建议的门诊流感监测和VE评估外，我们还建议 继续我们对流感VE和流感抗体发展的分析 从2010年开始，就有了一批有孩子的家庭。这批人将被用来 开展VE在预防任何严重程度的流感疾病方面的补充分析 通过持续的主动监视来确定。这个队列中的家庭被跟踪多年， 能够对重复接种疫苗进行准确评估。我们目前的招生策略将通过 针对有3岁以下儿童的家庭进行登记。将从成年人那里收集血液样本 和儿童每年两次；第三次血液样本将在4周后从3岁儿童身上采集 接种疫苗。拟议的工作将使我们能够继续建立、协调和多方面的 在门诊和社区环境中评估流感VE和抗体的发展。

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.