Project 1: COVID-19 prevalence, transmission, and protection in extended first responder cohorts

项目 1：扩大急救人员群体中的 COVID-19 流行率、传播和保护

• 批准号: 10688392
• 负责人: Eugene M Oltz
• 金额: $ 45.26万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10688392
• 关键词: Address; Antibodies; Antibody Response; Antibody-mediated protection; Area; Bioethics; Biological Assay; Biometry; Blood; COVID-19; COVID-19 pandemic; Categories; Child; Collection; Communication; Communities; Data; Diagnostic Reagent Kits; Discipline; Emergency Medicine; Epidemiology; Evaluation; Evolution; Funding; Genetic; Goals; Household; Immune response; Immunology; Individual; Infection; Infectious Disease Epidemiology; Infrastructure; Institution; Knowledge; Longitudinal Studies; Metadata; Methods; Monitor; Monoclonal Antibodies; Ohio; Online Systems; Participant; Pathologic; Pathology; Prevalence; Questionnaire Designs; Research; Research Personnel; Reverse Transcriptase Polymerase Chain Reaction; Risk; SARS-CoV-2 exposure; SARS-CoV-2 infection; SARS-CoV-2 positive; SARS-CoV-2 transmission; Saliva; Sampling; Serology; Serology test; Symptoms; System; Test Result; Testing; Universities; Vaccination; Vaccines; Viral; Viral Load result; Virus; Workplace; associated symptom; biobank; cohort; convalescent plasma; coronavirus disease; design; first responder; flexibility; genetic analysis; high risk; improved outcome; insight; nasopharyngeal swab; novel; pandemic disease; post SARS-CoV-2 infection; recruit; research clinical testing; response; sample collection; stem; transmission process; vaccine access; virology

PROJECT 1 SUMMARY The rapid spread COVID-19 and its extreme range of pathologies creates an urgent need to understand transmission and levels of protection following SARS-CoV-2 infection. These issues are most effectively studied in cohorts with individuals at high risk of exposure and, critically, their most frequent contacts. Project 1 will answer pressing questions about COVID-19 transmission and protection in such a group, Columbus, OH first responders and their household contacts. Longitudinal serology and virus testing will be performed over the next five years by the Project 1 team to determine COVID-19 prevalence, transmission, and protection in this cohort. An inherent feature of the research plan is its flexibility, also allowing us to pivot serological/viral tracking when vaccines are available, which, likely, will be deployed in a first stage to this high-risk cohort. We will employ a panel of serological and genetic assays, developed or validated at our institution, to address key knowledge gaps about COVID-19, including: (i) prevalence among a high-risk exposure group, (ii) causal relationships with PPE practices, (iii) transmission among household contacts, (iii) viral load and whether positive PCR results equate with infectious virus, (iv) evolution and durability of Ab responses to natural infection and re-infection over a range of symptoms, (v) humoral immune responses post-vaccination in naïve and previously infected individuals, and (vi) protection from re-infection or infection post-vaccination. Importantly, Project 1 studies will benefit from an OSU commitment to fund our proposed clinical testing. The project also will benefit from integration of transdisciplinary experts from emergency medicine, immunology, virology, pathology, infectious disease, epidemiology, biostatistics, and bioethics, as well as partnerships with local/state agencies. Project 1 will be accomplished in two Aims. AIM 1. Enhance existing infrastructure to longitudinally sample a cohort of first responders, staff, and household contacts. We have established a high buy-in rate for participation of this high-exposure risk group in the Columbus area (anticipated lower limit recruitment of ~2,500). AIM 2. Determine duration and protectiveness of antibody responses in STOP-COVID participants. We expect to enlist a broad spectrum of participants who, during the study, will include naïve, previously exposed, asymptomatic, and symptomatic individuals. We will leverage longitudinal serologic data to track all categories of exposed individuals for the magnitude, duration, neutralizing capacity, and protectiveness of antibody responses. When a vaccine is available, participants will provide a closely tracked cohort of priority recipients to monitor humoral immune responses to the vaccine in naïve and previously exposed individuals at a high risk for re-exposure. These studies will synergize with: Project 2 for an in-depth characterization of the immune responses and virus strains, with Core B for basic antibody and virus testing, with Core C for project design, epidemiology, and biostatistics, and will provide data to Project 3 for communication of test results and their implications with diverse groups.

项目1摘要 快速蔓延的covid-19及其极端的病理范围迫切需要了解 SARS-COV-2感染后的传播和保护水平。这些问题是最有效的 与具有高暴露风险的人一起研究，并批判性地接触。项目1 将回答有关COVID-19的迫切问题，俄亥俄州哥伦布，俄亥俄州哥伦布 急救人员及其家庭联系。纵向血清学和病毒测试将进行 项目1团队的未来五年，以确定Covid-19的患病率，传播和保护 这个队列。研究计划的继承特征是它的灵活性，也使我们能够旋转血清学/病毒 跟踪何时可用的疫苗，可能会在此高风险队列的第一阶段部署。 我们将采用一系列在我们机构开发或验证的血清学和遗传测定面板， 解决有关COVID-19的关键知识差距，包括：（i）高风险暴露组的流行，（ii） 与PPE实践的因果关系，（iii）家庭接触之间的传播，（iii）病毒载荷和 阳性PCR是否与传染病毒相等，（iv）AB反应的进化和耐用性 自然感染和重新感染一系列症状，（v）疫苗接种后体液免疫反应 幼稚和先前感染的个体，以及（vi）免受接种后再感染或感染的保护。 重要的是，项目1研究将受益于OSU的承诺，以资助我们提出的临床 测试。该项目还将受益于急诊医学的跨学科专家的整合， 免疫学，病毒学，病理学，传染病，流行病学，生物阶层和生物伦理学以及 与地方/州机构的合作伙伴关系。项目1将以两个目标完成。目标1。增强现有 纵向对基础设施进行样品，对第一响应者，员工和家庭联系人进行样品。我们有 为这个高曝光风险组在哥伦布地区的参与率建立了高的买入率 （预计下限招募约为2,500）。目标2。确定抗体的持续时间和保护性 停止参与者的回应。我们希望能吸引各种各样的参与者 研究将包括幼稚的，以前暴露的，无症状和有症状的个体。我们将利用 纵向血清学数据以跟踪所有类别的暴露个人，持续时间， 中和能力和抗体反应的保护性。当有疫苗可用时，参与者将 提供密切跟踪的优先接收者队列，以监测对疫苗的体液免疫反应 幼稚和以前暴露的人有重新暴露风险。这些研究将与： 项目2用于对免疫复杂和病毒菌株的深入表征，核心B用于基本 抗体和病毒测试，具有用于项目设计，流行病学和生物统计学的核心C，并将提供数据 项目3进行测试结果的交流及其与潜水员群体的影响。