Clinical Core

临床核心

• 批准号: 10599207
• 负责人: Asuncion Mejias
• 金额: $ 31.84万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10599207
• 关键词: 2019-nCoV; Age; Biological Assay; Blood; COVID-19; COVID-19 vaccination; Child; Clinical; Clinical Data; Clinical Distribution; Data Analyses; Data Collection; Development; Doctor of Medicine; Enrollment; Goals; Human; Immune; Immunology procedure; Infant; Infection; Influenza; Influenza vaccination; Life; Longitudinal cohort; Measurement; Measures; Nasopharynx; Patients; Performance; Principal Investigator; Resources; SARS-CoV-2 infection; Sampling; Shapes; Time; Viral; Viral Load result; Viral Respiratory Tract Infection; data curation; data exchange; data integration; data management; follow-up; improved; influenza infection; influenzavirus; nasopharyngeal swab; participant enrollment; programs; respiratory; synergism

Clinical Core Principal Investigator: Asuncion Mejias, M.D. Abstract This Core will serve three main goals. First, by enrolling all patients, obtaining the human samples, and collecting the clinical data it will simplify sample organization, data management and compliance with all regulatory aspects of the U19. In addition, the Clinical Core will support Projects 1 and 2, by performing the viral PCR assays, which will improve analytical performance and efficiency; and the Data Management Core, by coordinating and sharing de-identified clinical data. Specifically, the Core will be responsible for: 1) enrolling infants in the first 6 months of life with influenza or SARS-CoV-2 infection, as well as healthy non-infected controls, and obtaining sequential blood and respiratory samples pre and post influenza and COVID-19 vaccination during the first 3 years of life; 2) sample organization and distribution between Projects (1 and 2); 3) longitudinal clinical data collection, data curation and data transfer to the Data Management Core for data analyses and integration with all immune assays; 4) measure influenza and SARS-CoV-2 viral loads by quantitative real-time PCR in clinical samples (nasopharyngeal swabs) from infants with influenza or SARS-CoV-2 infection. This approach will optimize the use of resources and will facilitate integration and synergy among all projects.

临床核心 首席研究员：Asuncion Mejias，医学博士 抽象的 该核心将服务于三个主要目标。首先，招募所有患者，获取人体样本并收集 临床数据它将简化样本组织、数据管理和所有监管方面的合规性 U19 的。此外，临床核心将通过进行病毒 PCR 检测来支持项目 1 和 2， 这将提高分析性能和效率；和数据管理核心，通过协调和 共享去识别化的临床数据。 具体而言，核心将负责：1) 招募出生后 6 个月内患有流感或患有流感的婴儿 SARS-CoV-2 感染以及健康的未感染对照，并获得连续的血液和呼吸道样本 生命头 3 年内流感和 COVID-19 疫苗接种前后的样本； 2）样本组织 以及项目（1 和 2）之间的分配； 3）纵向临床数据收集、数据整理和数据 传输到数据管理核心进行数据分析并与所有免疫测定集成； 4) 测量 通过临床样本（鼻咽拭子）中的定量实时 PCR 检测流感和 SARS-CoV-2 病毒载量 来自患有流感或 SARS-CoV-2 感染的婴儿。这种方法将优化资源的使用，并将 促进所有项目之间的整合和协同。