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

RFA-IP-22-004，在大型、多样化的医疗保健系统中评估呼吸道病毒疫苗的有效性

• 批准号: 10703261
• 负责人: RICHARD K ZIMMERMAN
• 金额: $ 190万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10703261
• 关键词: RFA; IP; 22; 004; Evaluating

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.

摘要——A部分 我们正在申请 RFA 成分 A 和 D。本摘要指的是成分 A。流感/肺炎 包括美国第 9 大死因，COVID-19 是美国第 3 大死因，该流行病已进入第 3 大死因 疫苗有效性（VE）估计因宿主因素、病毒进化枝、与流行病毒的匹配、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 网络的组成部分，为流感- enza 和 COVID-19 VE 估计在当前 7 个网络站点中，PittVax 在注册人数方面排名第 2。 在血斑采集方面，以及在 PittVax 入组目标上超额完成后续调查方面排名第一。 已在该领域发表超过 300 篇同行评审文章。 我们提议在 UPMC 和联邦合格健康机构之间进行一项测试阴性病例对照设计 (TND) 研究 中心 (FQHC) 门诊患者可确定流感、COVID-19 以及可能的其他呼吸道病毒 VE。 具体目标是： 1) 根据实验室确诊、医疗救治的急性呼吸道感染确定 VE 流感季节期间 1000-1200 名门诊患者的感染情况，按年龄组划分：6 岁至 18 岁、19-49 岁、 且≥50岁，在呼吸季节期间的现场登记中使用测试阴性设计加上远程登记 流感季节之外的治疗（如果 COVID-19 持续存在，则另外 400-900 次）；2) 提供基因测序 选定样本以了解进化枝的双周趋势；3) 确定基于种群的年度负担； UPMC 健康计划中阿勒格尼县（匹兹堡）的流感和 COVID-19。 在最高比例的参与者中，既往感染过 SARS-CoV-2（例如 N 蛋白），我们建议 威廉姆斯实验室使用vali- 进行了更深入的研究，并在一个子集上补充了血清。 日期为 RT-PCR 的 96 孔板仪器，在过去 6 年中分析了超过 10,000 个样本 流感、SARS-CoV-2 和其他呼吸道病毒，将确定感染病毒的存在。 有经验的哈里森实验室将进行病毒基因组测序，我们将从中获得免疫记录。 州登记处以及 UPMC 和 FQHC 的电子记录。 UPMC Health Plan 是阿勒格尼县最大的保险公司，2021-22 年在 UPMC 覆盖超过 126,000 个县 UPMC 每年对居民进行 SARS-CoV-2 临床检测，门诊量超过 560 万人次。 每年 140 万 UPMC 急诊科就诊接受急诊科 (ED) 和紧急护理评估 2021 年，我们的四个招募人员中，通过共同结构和电子记录进行了 305,751 次急诊就诊 UPMC 连续 23 年被评为网络最完善的卫生系统之一。 我们将主要为黑人股权联盟的有色人种和领导层提供服务的 FQHC 办事处添加到我们的 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 从健康公平的角度来看，健康数据和传播研究结果的重要因素。