Michigan-Ford Initiative to Measure Vaccine Effectiveness (MFIVE): Seasonal Influenza, COVID-19 and Respiratory Virus Vaccines

组成部分A：密歇根-福特衡量疫苗有效性倡议(MFIVE)：季节性流感， 新冠肺炎和呼吸道病毒疫苗的使用情况积极监测医护人员参加急性呼吸综合征 门诊中的呼吸道疾病(Maari)一直是疫苗有效性(VE)的基石 在美国进行了十多年的监测。作为美国流感VE网络的一部分，密歇根州 呼吸道病毒研究和响应中心拥有专业知识和基础设施，可以在 支持对SARS-CoV-2和流感进行实时VE评估的先前测试阴性研究的结果 疫苗。我们的主要目标是在之前评估疫苗有效性的基础上再接再厉 在预防SARS-CoV-2和流感方面的应用。我们将在整个过程中进行VE监控 通过招募在门诊诊所和检测中心就诊的患者 跨越两个医疗保健系统。我们的注册站点分布在多个社区中 区域，包括为受传染病影响较大的人群提供服务的诊所。这项研究将 综合分析抗体、病毒全基因组序列，以及检测非流感、非流感和 SARS-CoV-2呼吸道病毒(如RSV)。我们将利用这些评估来扩大测试阴性的范围 为VE提供更准确和可靠的评估的方法。我们的具体目标如下： 目标1.从以下方面确定流感疫苗和新冠肺炎疫苗在儿童和成人中的疫苗效力 可移动设置。我们将通过积极招募有Maari、收集和测试的个人来做到这一点 对呼吸道样本进行监测，核实健康数据和疫苗接种史。 目的2.对流感和SARS-CoV-2进行病毒基因组测序，用于监测和支持 对VE的不同估计和特定于分支的估计。我们将利用我们现有的强大测序流水线来提供 及时对来自研究和临床收集的呼吸道样本的数据进行排序。 目标3.有效维持SARS-CoV-2监测和新冠肺炎疫苗效力评估 在流感病毒未传播期间的门诊患者中。我们会做到这一点的 通过标准化查询我们两个参与的主要医疗中心的电子病历， 与国家疫苗接种登记数据定期整合。我们的主要成果将是快速确定 疫苗效力，通过定期向疾病预防控制中心提供支持，以支持对普通人群的疫苗建议 并为未来疫苗的选择和开发提供信息。

Component A: Michigan-Ford Initiative to Measure Vaccine Effectiveness (MFIVE): Seasonal Influenza, COVID-19, and Respiratory Virus Vaccines The use of active surveillance for medically-attended acute respiratory illness (MAARI) in outpatient settings has been the cornerstone of vaccine effectiveness (VE) monitoring in the U.S. for over a decade. As a part of the U.S. Flu VE Network for 10 years, the Michigan Center for Respiratory Virus Research and Response has the expertise and the infrastructure to build upon the findings of previous test-negative studies to support real-time VE assessments for SARS-CoV-2 and influenza vaccines. Our primary goal is to build upon our previous efforts to evaluate the effectiveness of vaccines against SARS-CoV-2 and influenza in prevention of MAARI. We will conduct VE surveillance throughout Southeastern Michigan through recruitment of patients presenting at ambulatory clinics and testing centers spanning two healthcare systems. Our enrollment sites are distributed throughout multiple communities in the region, including clinics serving populations disproportionately impacted by infectious diseases. This study will integrate analyses of antibodies, whole genome sequences of viruses, and detection of non-influenza, non- SARS-CoV-2 respiratory viruses (e.g. RSV). We will use these evaluations to expand upon the test-negative methodology to provide a more accurate and robust assessment of VE. Our specific objectives are as follows: Objective 1. Determine vaccine effectiveness of influenza and COVID-19 vaccines in children and adults from ambulatory settings. We will do this through active enrollment of individuals with MAARI, collection and testing of respiratory specimens, and verification of health data and vaccination history. Objective 2. Conduct viral genomic sequencing of influenza and SARS-CoV-2 for surveillance and to support variant and clade-specific estimates of VE. We will leverage our existing, robust sequencing pipeline to provide timely sequencing data from both research and clinically-collected respiratory specimens. Objective 3. Efficiently maintain SARS-CoV-2 surveillance and COVID-19 vaccine effectiveness evaluations among ambulatory patients during periods when influenza viruses are not circulating. We will accomplish this through standardized queries of the electronic medical records of our two participating major medical centers, with regular integration with state vaccination registry data. Our primary outcome will be rapid determinations of vaccine effectiveness, through regular deliveries to CDC to support vaccine recommendations for the general population and to inform selection and development of future vaccines.