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概要 快速传播的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 在暴露风险高的人群中进行了研究，关键是，他们最频繁的接触。项目1 我将在俄亥俄州哥伦布的这样一个小组中回答有关COVID-19传播和保护的紧迫问题 第一反应者和他们的家庭联系人。纵向血清学和病毒检测将在 未来五年，由项目1团队确定COVID-19的流行、传播和保护， 这个cohort。研究计划的一个固有特点是其灵活性，也使我们能够将血清学/病毒学 跟踪疫苗何时可用，这些疫苗可能会在第一阶段部署到这个高风险队列。 我们将采用一组在我们机构开发或验证的血清学和遗传学检测， 解决有关COVID-19的关键知识差距，包括：（i）高风险暴露群体的患病率，（ii） 与个人防护设备做法的因果关系，（iii）家庭接触者之间的传播，（iii）病毒载量， 阳性PCR结果是否等同于感染性病毒，（iv）Ab应答的演变和持久性， 自然感染和一系列症状的再感染，（v）接种疫苗后的体液免疫应答， 初次感染和先前感染的个体，和（vi）防止再感染或接种后感染。 重要的是，项目1的研究将受益于俄勒冈州立大学的承诺，以资助我们提出的临床研究。 试验.该项目还将受益于急诊医学、 免疫学、病毒学、病理学、传染病、流行病学、生物统计学和生物伦理学，以及 与地方/州机构的伙伴关系。项目1将在两个目标中完成。AIM 1.增强现有 基础设施，对一组急救人员、工作人员和家庭接触者进行纵向抽样。我们有 为哥伦布地区这一高风险群体的参与制定了高买入率 （预计招募下限约为2 500人）。AIM 2.确定抗体的持续时间和保护性 STOP-COVID参与者的反应。我们希望争取广泛的参与者，他们在 研究将包括初治、既往暴露、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体的程度，持续时间， 中和能力和抗体应答的保护性。当疫苗可用时，参与者将 提供一个密切跟踪的优先接种者队列，以监测对疫苗的体液免疫反应， 初次接触和以前接触过的人再次接触的风险很高。这些研究将与以下方面产生协同作用： 项目2用于深入表征免疫应答和病毒株，核心B用于基本 抗体和病毒检测，核心C用于项目设计、流行病学和生物统计学，并将提供数据 项目3，用于与不同群体交流测试结果及其含义。