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

摘要-组分A 我们正在申请RFA组件A和D。本摘要涉及组分A。流感/肺炎 包括美国第九大死因和第三大死因COVID-19，随着疫情进入第三个 年疫苗有效性（VE）估计值因宿主因素、病毒进化枝、与循环病毒的匹配、时间 由于疫苗接种（即，减弱）和特定的疫苗特性。 PittVax和合作者12年来一直是美国流感VE网络的组成部分，为流感病毒的传播做出了贡献。 enza和COVID-19 VE估计。在目前的7个网络站点中，PittVax的注册人数排名第2， 在血斑采集方面排名第一，在随访调查完成方面排名第一，同时超过了招募目标。PittVax 在该领域发表了超过300篇同行评议的文章。 我们提出了一个测试阴性病例对照设计（TND）研究中UPMC和联邦合格的健康 中心（CIMHC）门诊患者，以确定流感，COVID-19和可能的其他呼吸道病毒VE。我们 具体目标是：1）确定VE对实验室确认，医疗照顾，急性呼吸道感染- 在流感季节，1000-1200名门诊患者中的感染，年龄组为：6个月-18岁，19-49岁， 和≥50岁，在呼吸季节现场入组中使用检测阴性设计加上远程入组- 流感季节以外的时间（如果COVID-19持续存在，另外400-900）; 2）提供基因测序， 选择标本的进化枝的双周趋势;和3）确定每年，人口为基础的负担， 从UPMC健康计划中为阿勒格尼县（匹兹堡）提供流感和COVID-19。用于确定 先前感染SARS-CoV-2（例如，N蛋白）的参与者比例最高，我们建议手指- 粘血斑，辅以血清上的一个子集，进行更深入的研究。威廉姆斯实验室，使用vali- 用于RT-PCR的96孔板仪器，在过去6年中分析了超过10，000份标本， 流感病毒、SARS-CoV-2和其他呼吸道病毒，将确定感染病毒的存在。前- 哈里森实验室将进行病毒基因组测序。我们会向 国家的登记册和UPMC的和CNOHC的电子记录。 UPMC健康计划是阿勒格尼县最大的保险公司，2021-22年UPMC的保险公司超过126，000个县 对居民进行了SARS-CoV-2临床检测。UPMC每年记录超过560万次门诊就诊。超过 1.4每年在急诊科（ED）和紧急护理中心评估100万次UPMC急性护理就诊 2021年，我们招募的四家艾德诊所中， EDs. UPMC被评为23年来最有线的卫生系统之一。为了解决卫生公平问题， 我们将主要为有色人种和黑人平等联盟领导人服务的黑人平等委员会办事处增加到我们的 多学科小组协助制定文化上胜任的脚本/调查，纳入社会威慑因素， 从健康公平的角度维护健康数据和传播调查结果。

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.