RFA-IP-22-004, Evaluating respiratory virus vaccine effectiveness in a large, diverse healthcare system

摘要-组件A 我们正在申请A组分和D组分。本摘要指的是A组分流感/肺炎。 占美国死因第9位和新冠肺炎第3位，大流行已进入第3位 年。疫苗有效性(VE)评估因宿主因素、病毒分支、与传播病毒的匹配、时间而异 由于疫苗接种(即减弱)和特定的疫苗特性。 12年来，PittVax及其合作者一直是美国流感VE网络不可或缺的一部分，为感染- 恩萨和新冠肺炎VE估计。在目前的7个社交网站中，PittVax的注册人数排名第二，排名第二 在血斑收集中排名第一，在后续调查完成时排名第一，同时超过招生目标。PittVax 发表了该领域的300篇同行评议文章。 我们提出了一项在UPMC和联邦合格健康人群中进行的试验阴性病例对照设计(TND)研究 口蹄疫中心(FQHC)门诊患者确定流感、新冠肺炎，并可能确定其他呼吸道病毒VE。我们的 具体目标是：1)确定VE与实验室确认的、有医疗护理的、急性呼吸道感染- 流感季节1,000-1,200名门诊病人感染的年龄组：6个月-18岁，19-49岁， 和≥50年，在呼吸季现场注册中使用测试阴性设计，加上远程注册- 在流感季节以外的地方(如果新冠肺炎持续存在，还会有4-900个)；2)提供 选定的样本用于分支的双周趋势；以及3)确定每年以人口为基础的负担 阿勒格尼县(匹兹堡)的流感和新冠肺炎，来自UPMC卫生计划。用于确定 在既往感染SARS-CoV-2(如N蛋白)的参与者比例最高的情况下，我们建议手指- 涂抹血斑，辅以子集的血清，以进行更深入的研究。威廉姆斯实验室，使用瓦利- 用于RT-PCR的96孔板仪器，它在过去6年中分析了10,000个样品 流感、SARS-CoV-2和其他呼吸道病毒，将确定是否存在感染病毒。前任- 哈里森实验室将进行病毒基因组测序。我们会向 从该州的登记处以及UPMC和FQHC的电子记录中获取。 UPMC Health Plan是阿勒格尼县最大的保险公司，2021-22年在UPMC，&>12.6万县 居民接受了SARS-CoV-2的临床检测。每年，UPMC记录了560万人次的门诊就诊。完毕 UPMC每年在急诊科和紧急护理部门评估140万次急性护理就诊 通过共同的结构和电子记录的诊所，2021年在我们的四个招聘中有305,751个急诊室就诊 埃兹。23年来，UPMC一直被评为联网最多的医疗系统之一。为了解决卫生公平问题， 我们增加了FQHC办公室，主要服务于黑人权益联盟的有色人种和领导层 多学科团队协助制定具有文化能力的脚本/调查，纳入社会威慑因素- 从卫生公平的角度考虑卫生数据的采集和研究结果的传播。

Abstract – Component A We are applying for RFA components A and D. This abstract refers to Component A. Influenza/pneumonia comprise the 9th and COVID-19 the 3rd leading cause of death in the U.S., with the pandemic entering its 3rd year. Vaccine effectiveness (VE) estimates vary by host factors, viral clade, match to circulating virus, time since vaccination (i.e., waning) and specific vaccine characteristics. PittVax and collaborators have been integral to the US Flu VE Network for 12 years, contributing to influ- enza and COVID-19 VE estimates. Among the current 7 Network sites, PittVax ranks #2 in enrollments, #2 in bloodspot collections, and #1 in follow-up survey completion, while exceeding enrollment goals. PittVax has published >300 peer-reviewed articles in the field. We propose a test-negative case-control design (TND) study among UPMC and federally qualified health center (FQHC) outpatients to determine influenza, COVID-19 and possibly, other respiratory virus VE. Our specific aims are: 1) Determine VE against laboratory-confirmed, medically-attended, acute respiratory in- fections among 1000-1200 outpatients during the influenza season in age groups: 6 mos-18 yrs, 19-49 yrs, and ≥50 yrs, using test negative design in onsite enrollment during respiratory season plus remote enroll- ment outside of influenza season (another 400-900 if COVID-19 persists); 2) provide genetic sequencing on selected specimens for biweekly trends in clade; and 3) determine the annual, population-based burden of influenza and COVID-19 for Allegheny County (Pittsburgh) from the UPMC Health Plan. For determining prior infection for SARS-CoV-2 (e.g., N protein) in the highest proportion of participants, we propose finger- stick bloodspots, supplemented by sera on a subset, for more in-depth studies. The Williams lab, using vali- dated 96-well plate instruments for RT-PCR, which analyzed >10,000 specimens over the last 6 years for influenza, SARS-CoV-2 and other respiratory viruses, will determine presence of infecting viruses. The ex- perienced Harrison lab will perform viral genomic sequencing. We will obtain immunization records from the state’s registry and from UPMC’s and the FQHC’s electronic records. UPMC Health Plan is the largest insurer in Allegheny County and at UPMC in 2021-22, >126,000 county residents were clinically tested for SARS-CoV-2. Annually, UPMC records >5.6 million outpatient visits. Over 1.4 million UPMC acute care visits a year are assessed at Emergency Departments (EDs) and Urgent Care clinics through a common structure and e-record with 305,751 ED visits in 2021 among our four recruiting EDs. UPMC has been rated one of the most wired health systems for 23 years. To address health equity, we add FQHC offices serving mostly persons of color and leadership from the Black Equity Coalition to our multidisciplinary team to assist with culturally competent script/survey development, inclusion of social deter- minants of health data and dissemination of findings with a health equity perspective.