RFA-IP-22-004, Evaluating influenza, SARS-CoV-2, and other respiratory virus vaccine effectiveness in prevention of acute illness in Washington state 2022-2027

RFA-IP-22-004，评估 2022-2027 年华盛顿州流感、SARS-CoV-2 和其他呼吸道病毒疫苗预防急性疾病的有效性

• 批准号: 10698201
• 负责人: Karen J Wernli
• 金额: $ 140万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 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 2027-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698201
• 关键词: RFA; IP; 22; 004; Evaluating

ABSTRACT As one of the current US Influenza Vaccine Effectiveness (US Flu VE) Network sites, we propose continuing our studies of vaccine effectiveness (VE) for seasonal influenza, COVID-19, and other respiratory viruses to prevent acute respiratory illness (ARI) in Washington state from 2022 to 2027 (Component A). Since March 2020, the COVID-19 pandemic has resulted in >80 million infections and ~1 million US deaths. Until the pandemic, the dominant respiratory virus impacting public health seasonally was influenza. In the US, up to 5% of the population sought outpatient care during a severe epidemic, and a typical epidemic caused tens of thousands of deaths and hundreds of thousands of hospitalizations. The COVID-19 pandemic catalyzed rapid adoption of telehealth care, in particular for patients with mild to moderate ARI, shifting patients from ambulatory visits to minimize healthcare exposure to COVID-19. Currently, influenza and COVID-19 vaccinations are the best available tools for reducing the respiratory virus burden and maintaining population immunity. Vaccination programs represent a substantial public health investment. Given the magnitude of this investment and the dynamic impact of respiratory viruses on public health, policymakers need accurate, timely, and relevant data representing real-world VE to monitor the impact on respiratory illness burden in US populations. The next 5 years of surveillance of respiratory illness in US populations will be critical in accounting for changes in respiratory virus burden. The US Flu VE Network has the capacity, infrastructure, research methods, and specimen collection experience to monitor any respiratory virus within US health care. From 2022-2027, we propose to enroll ~6000 KPWA infants, children, and adults including older adults in urgent care clinics, collect respiratory and blood specimens, complete enrollment and post-enrollment questionnaires, collaborate with laboratory services to type and genetically sequence specimens, collate and curate EHR data, collaborate across the Network with Component A sites, share data with Network Coordination Center (Component B), share specimens with site leading Component E, participate in Network research activities including dissemination, and develop new methods for estimation and inference in VE. Our specific aims to meet the goals of the US Flu VE Network are: Aim 1. Establish a platform to estimate VE of seasonal influenza and COVID-19 vaccines against respiratory viral illnesses in preventing laboratory- confirmed illness among children and adults with mild or moderate illness seeking care in ambulatory settings (Objective 1); Aim 2. Establish a protocol to obtain influenza and SARS-CoV-2 viral sequences from specimens collected among infected participants in the proposed outpatient network (Objective 2); Aim 3. Describe capacity and diagnostic test methods available in KPWA and methods to obtain COVID-19 vaccination data outside influenza season (Objective 3). Aim 4. Improve precision of the test-negative design by incorporate two-phase sampling methodology (methods aim).

摘要 作为目前美国流感疫苗有效性(US Flu VE)网络网站之一，我们建议继续 我们对季节性流感、新冠肺炎和其他呼吸道病毒的疫苗效力(VE)研究 2022年至2027年华盛顿州预防急性呼吸道疾病(ARI)(A部分)。自3月以来 2020年，新冠肺炎大流行已导致8000万人感染，约100万美国人死亡。直到 在大流行期间，季节性影响公共卫生的主要呼吸道病毒是流感。在美国，高达5% 8%的人在严重疫情期间寻求门诊治疗，而一次典型的疫情导致数十人 数千人死亡，数十万人住院。新冠肺炎大流行催生了 采用远程医疗保健，特别是对于轻到中度ARI的患者，将患者从 门诊就诊，最大限度地减少医疗保健对新冠肺炎的暴露。目前，流感和新冠肺炎 接种疫苗是减少呼吸道病毒负担和维持人口数量的最佳工具 豁免权。疫苗接种计划是一项可观的公共卫生投资。考虑到这件事的严重性 投资和呼吸道病毒对公共卫生的动态影响，政策制定者需要准确、及时、 和代表真实世界VE的相关数据，以监测对美国呼吸系统疾病负担的影响 人口。未来5年对美国人口呼吸道疾病的监测将是关键 考虑到呼吸道病毒负担的变化。美国流感VE网络有能力，基础设施， 研究方法和样本采集经验，以监测美国医疗保健中的任何呼吸道病毒。 从2022年到2027年，我们建议招收约6000名KPWA婴儿、儿童和成年人，包括老年人 紧急护理诊所，采集呼吸道和血液样本，完成注册和注册后 问卷调查，与实验室服务合作，对样本进行分类和基因排序，整理和 管理电子病历数据、跨网络与A组分站点协作、与网络共享数据 协调中心(B组件)，与现场主导组件E共享标本，参与网络 研究活动，包括传播，并开发在虚拟环境中估计和推断的新方法。我们的 实现美国流感VE网络目标的具体目标是：目标1.建立一个评估VE的平台 季节性流感和新冠肺炎疫苗在实验室预防呼吸道病毒疾病- 在门诊就诊的轻度或中度疾病的儿童和成人中确诊的疾病 (目标1)；目标2.建立获取流感和SARS-CoV-2病毒序列的方案 在拟议的门诊网络感染参与者中收集的样本(目标2)；目标3。 描述KPWA可用的容量和诊断测试方法以及获得新冠肺炎的方法 流感季节以外的疫苗接种数据(目标3)。目的4.提高试验阴性设计的精确度 采用两阶段抽样法(方法目的)。