RFA-IP-22-004, Multidisciplinary Approach to Understanding Vaccine Efficacy and Transmission of Viral Respiratory Tract Infections in the Real World

RFA-IP-22-004，了解疫苗功效和现实世界中病毒呼吸道感染传播的多学科方法

• 批准号: 10703257
• 负责人: Stacey House
• 金额: $ 190万
• 依托单位: WASHINGTON UNIVERSITY
• 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/10703257
• 关键词: RFA; IP; 22; 004; Multidisciplinary

PROJECT SUMMARY/ABSTRACT – COMPONENT A Influenza and SARS-CoV-2 are major causes of morbidity and mortality and constitute the leading causes of vaccine preventable deaths in the United States. A better understanding of vaccine effectiveness for these viral pathogens is critical to drive public health decisions and interventions. We propose utilizing a multidisciplinary approach to conduct a test-negative study to determine influenza and SARS-CoV-2 vaccine effectiveness in ambulatory patients with respiratory tract infections. The team of investigators includes experts in emergency medicine, infectious disease, pediatrics, epidemiology, information technology, molecular microbiology, virology, and genetics. This team has extensive experience in automated electronic medical record alerts, high-volume subject recruitment of ambulatory patients with respiratory tract infections, rapid escalation/de-escalation of recruitment efforts to match viral circulation patterns, respiratory and blood sample processing and shipment, quality data collection and verification, and viral genomic sequencing necessary to ensure the success of this project. The proposed study will encompass the following specific aims: 1)Utilize innovative automated alerting strategies to identify and recruit a diverse population of ambulatory patients with acute respiratory illnesses; 2) Estimate influenza and SARS-CoV-2 vaccine effectiveness using a test- negative study design in the general population as well as different demographic subgroups.; 3) Explore factors that influence influenza and SARS-CoV-2 vaccine effectiveness such as co-morbidities, vaccination type and schedule, and social determinants of health; 4) Determine effect of viral vaccination status on health outcomes in ambulatory patients with influenza and SARS-CoV-2 infection; 5) Contribute biospecimens and viral genomic sequencing data to a national repository of subjects with PCR-confirmed influenza or SARS-CoV-2 infection. To accomplish these goals, we will enroll at least 1000 ambulatory patients/year with acute respiratory tract infections in the proposed study. The subject population will be identified from the emergency departments of 3 large hospitals in the St. Louis area and their associated outpatient clinics. The available patient population at these enrolling sites is diverse with respect to race, ethnicity, age, socioeconomic status, and medical care access which will enhance the generalizability of the study outcomes to the US population.

项目概要/摘要 – 组成部分 A 流感和 SARS-CoV-2 是发病率和死亡率的主要原因，并构成了主要疾病 美国疫苗可预防死亡的原因 更好地了解疫苗。 针对这些病毒病原体的有效性对于推动公共卫生决策和干预措施至关重要。 建议利用多学科方法进行测试阴性研究以确定流感 SARS-CoV-2 疫苗对流动呼吸道感染患者的有效性。 研究小组包括急诊医学、传染病、儿科、 该团队拥有流行病学、信息技术、分子微生物学、病毒学和遗传学。 在自动化电子病历警报、大容量受试者招募方面拥有丰富的经验 患有呼吸道感染的门诊患者，招募快速升级/降级 匹配病毒循环模式、呼吸努力和血液样本处理和运输， 确保成功所需的高质量数据收集和验证以及病毒基因组测序 该项目的研究将包括以下具体目标：1）利用创新 自动警报策略，用于识别和招募不同的门诊患者群体 急性呼吸道疾病；2) 使用测试评估流感和 SARS-CoV-2 疫苗的有效性 总体人群以及不同人口亚组的负面研究设计。 3) 探索 影响流感和 SARS-CoV-2 疫苗有效性的因素，例如合并症、 疫苗接种类型和时间表以及健康的社会决定因素；4) 确定病毒的影响； 疫苗接种状况对流动流感和 SARS-CoV-2 感染患者健康结果的影响； 5) 将生物样本和病毒基因组测序数据贡献给国家受试者存储库 PCR 确诊的流感或 SARS-CoV-2 感染为了实现这些目标，我们至少将招募。 在拟议的研究中，每年有 1000 名患有急性呼吸道感染的流动患者。 将从圣路易斯地区3家大型医院的急诊科确定人群 这些登记地点的可用患者人数是 在种族、民族、年龄、社会经济地位和医疗保健获取方面具有多样性，这将 提高研究结果对美国人口的普遍性。