SARS-CoV-2 testing at the Seattle Vaccine and Prevention CRS (30331)

西雅图疫苗和预防 CRS 进行 SARS-CoV-2 检测 (30331)

基本信息

批准号：
10166485
负责人：
Margaret Juliana McElrath
金额：
$ 29.94万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-16 至 2021-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10166485
关键词：
2019-nCoV AIDS prevention Administrative Supplement Area COVID-19 Catalogs Clinical Research Clinical Trials Clinical Trials Unit Cohort Studies Communicable Diseases Communities Community Participation Country Development Disease Disease Outbreaks Enrollment Epidemic Evaluable Disease Goals HIV HIV Vaccine Trials Network HIV prevention trials network HIV vaccine Immunology Individual Infection Infection prevention Infrastructure Interpersonal Relations Intervention Trial Locales Location Modality Monoclonal Antibodies Natural History Participant Pathogenesis Patients Phase Prevention Prevention trial Preventive Preventive measure Preventive vaccine Procedures Process Protocols documentation Reporting Research Research Activity Site Structure Testing Therapeutic Time Translating United States National Institutes of Health Universities Vaccines Washington Work World Health Organization clinical research site cohort experience global health interest novel coronavirus pandemic disease prevent prevention clinical trial screening transmission process vaccine trial

项目摘要

Project Summary/Abstract On March 11, 2020, the World Health Organization declared that the rapid spread of the novel coronavirus, SARS-CoV-2, and its associated disease, COVID-19, had become a global pandemic. The ongoing crisis calls for the involvement of clinical research sites (CRSs) to work rapidly and efficiently toward therapeutic and preventative measures to control the epidemic. Our CRS, the Seattle Vaccine Trials Unit (VTU), has vast prior experience conducting observational cohort studies and phase 1-2b clinical trials of preventative HIV vaccines and other HIV prevention modalities. We propose bringing this infrastructure and experience to the field of SARS- CoV-2 clinical research. Our proposal is both to expand the scope of research activity at our CRS and to involve new venues for protocol conduct. Onsite CRS activity will encompass natural history studies of recovered COVID-19 patients, as well as early to late phase vaccine protocols. New venues will be opened and developed in order to effectively conduct COVID-19 research with appropriate infection prevention procedures to prevent SARS-CoV-2 transmission. Such new venues will include temporary structures that will provide capability to conduct clinical research in areas with continued SARS-CoV-2 transmission as specific areas with outbreaks are noted during the course of the epidemic.

项目概要/摘要 2020年3月11日，世界卫生组织宣布，新型冠状病毒的迅速传播， SARS-CoV-2 及其相关疾病 COVID-19 已成为全球流行病。持续的危机呼唤促进临床研究中心 (CRS) 的参与，快速有效地开展治疗和治疗工作采取预防措施控制疫情。我们的 CRS（西雅图疫苗试验单位 (VTU)）拥有大量先验知识进行预防性 HIV 疫苗观察性队列研究和 1-2b 期临床试验的经验和其他艾滋病毒预防方式。我们建议将这些基础设施和经验带入 SARS 领域—— CoV-2 临床研究。我们的建议是扩大 CRS 的研究活动范围并让礼宾行为的新场所。现场 CRS 活动将包括回收的自然历史研究 COVID-19 患者，以及早期到晚期的疫苗方案。新场馆将开放和开发为了通过适当的感染预防程序有效地进行 COVID-19 研究，以防止 SARS-CoV-2 传播。此类新场馆将包括临时建筑，以提供能力在 SARS-CoV-2 持续传播的地区开展临床研究，因为爆发的特定地区疫情期间注意到的。