Clinical Core

临床核心 主要调查者：亚松森·梅贾斯，医学博士。 摘要 这一核心将服务于三个主要目标。首先，通过招募所有患者，获取人体样本，并收集 它将简化样本组织、数据管理和遵守所有监管方面的临床数据 在U19公路上。此外，临床核心将支持项目1和项目2，通过进行病毒聚合酶链式反应分析， 这将提高分析性能和效率；以及数据管理核心，通过协调和 共享未识别的临床数据。 具体地说，该中心将负责：1)登记出生后头6个月患有流感或 SARS-CoV-2感染，以及健康非感染对照，并获得连续的血液和呼吸 生命头3年内接种流感疫苗和新冠肺炎疫苗前后的样本；2)样本组织 和项目之间的分配(1和2)；3)纵向临床数据收集、数据管理和数据 转移到数据管理核心进行数据分析并与所有免疫分析相集成；4)测量 临床标本(鼻咽拭子)中流感病毒和SARS-CoV-2病毒载量的实时定量聚合酶链式反应 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。

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.