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

项目摘要/摘要--构成部分A 流感和SARS-CoV-2是发病率和死亡率的主要原因，并构成主要 美国疫苗可预防死亡的原因。更好地了解疫苗 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至关重要。我们 建议利用多学科方法进行检测阴性的研究以确定流感 以及SARS-CoV-2疫苗在门诊呼吸道感染患者中的有效性。这个 调查团队包括急诊医学、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、大量受试者招聘方面拥有丰富的经验 对患有呼吸道感染的门诊患者，招募人数迅速上升/下降 努力匹配病毒传播模式、呼吸道和血液样本的处理和运输， 高质量的数据收集和验证，以及确保成功所需的病毒基因组测序 这个项目的。拟议的研究将包括以下具体目标：1)利用创新的 自动警报策略，以识别和招募不同的门诊患者群体 急性呼吸道疾病；2)使用以下测试评估流感和SARS-CoV-2疫苗的有效性- 一般人群和不同人口学亚组的负性研究设计；3)探索 影响流感和SARS-CoV-2疫苗效力的因素，如共病， 疫苗接种类型和计划，以及健康的社会决定因素；4)决定病毒的效果 流感和SARS-CoV-2感染门诊患者接种疫苗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生物信息库 经聚合酶链式反应确认为流感或SARS-CoV-2感染。为了实现这些目标，我们将至少招收 在拟议的研究中，1000名门诊患者/年患有急性呼吸道感染。主题是 人口将从圣路易斯地区3家大型医院的急诊科确定 及其相关的门诊诊所。这些登记地点的可用患者人数为 在种族、民族、年龄、社会经济地位和医疗保健方面的多样性，这将 增强研究结果在美国人群中的普适性。

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.