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: 10619886
• 负责人: Stacey House
• 金额: $ 248.39万
• 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/10619886
• 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是发病和死亡的主要原因， 美国疫苗可预防的死亡原因更好地了解疫苗 这些病毒病原体的有效性对于推动公共卫生决策和干预至关重要。我们 建议采用多学科方法进行检测阴性研究，以确定流感 和SARS-CoV-2疫苗在非卧床呼吸道感染患者中的有效性。的 调查小组包括急诊医学，传染病，儿科， 流行病学、信息技术、分子微生物学、病毒学和遗传学。这支球队有 在自动化电子病历警报、大量受试者招募方面拥有丰富的经验 呼吸道感染的非卧床患者，招募的快速升级/降级 努力匹配病毒循环模式、呼吸道和血液样本处理和运输， 高质量的数据收集和验证，以及确保成功所必需的病毒基因组测序 of this project项目.拟议的研究将包括以下具体目标：1）利用创新的 自动化警报策略，以识别和招募不同的门诊患者人群， 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- 在一般人群以及不同的人口统计学亚组中的阴性研究设计。3)探索 影响流感和SARS-CoV-2疫苗有效性的因素，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 流感和SARS-CoV-2感染的门诊患者的疫苗接种状况对健康结局的影响; 5)将生物标本和病毒基因组测序数据提供给国家受试者资料库， PCR证实的流感或SARS-CoV-2感染。为了实现这些目标，我们将至少 在拟定研究中，1000例急性呼吸道感染非卧床患者/年。受试者 将从圣路易斯地区3家大型医院的急诊室确定人群 及其附属门诊诊所。这些入组研究中心的可用患者人群为 在种族、民族、年龄、社会经济地位和医疗服务方面存在差异， 增强研究结果对美国人群的普遍性。