Clinical Core

项目摘要：临床核心 临床核心 (CC) 是 LJI HIPC 计划的组成部分。核心提供领导力和 管理所有临床样本和数据。这包括确保所有监管文件到位 LJI 和合作者机构的人类受试者研究、人员的适当培训和 监控重债穷国中心的所有临床研究活动，管理内部和外部样本的监督 收集，包括安排定期将样品运送至 LJI、样品存储、临床数据 我们的专业捐赠者记录管理系统 DoRAS 中的收集、监督以及收到样本的质量控制。 CC 确保对所有需要的样本进行 HLA 分型，并确保它与 用于确认样本完整性和身份的项目、测序、数据管理和分析核心 整个实验和生物信息学流程。 总体科学计划将为抗原特异性 T 细胞开发一系列免疫特征 响应多种呼吸道病原体，例如 SARS-CoV-2、普通感冒冠状病毒、 流感、结核病、肺炎球菌、百日咳和真菌（曲霉菌和念珠菌）。整个活动的成功 该计划取决于成功采集高质量人体样本和相关捐赠者 信息。获得足够数量和质量的此类样本面临着特殊的挑战，因为 该提案的重点是比较对不同呼吸道病原体有反应的 T 细胞，以及招募 来自几个截然不同的地理位置的个人。为了应对这些挑战，CC 将使用 从队列中获取样本（包括 PBMC、肺组织和 BAL）的成熟且经过验证的方法 与自然感染、持续性疾病和疫苗接种有关。用于该计划的队列将 可从我们完善的内部 LJI 临床研究中心 (CCI) 或我们的 经验丰富的合作者和临床医生，可以接触到独特的队列，并且与我们合作愉快 多年来富有成效的关系。我们对提供必要样品的能力充满信心 作为临床和科学输入，以实现最稳健和引人注目的研究。我们将继续招募 和已经建立的队列的样本采集，并在上下文中访问先前获得的样本 SARS-CoV-2 项目（项目 1）。此外，我们与博士建立了长期的合作关系。 Dharshan DeSilva（斯里兰卡）、Matt O'Shea（英国）、Maria Lerm（瑞典）、Cesar Ugarte（秘鲁）和 Richard Silver（美国）将提供潜伏结核感染或确诊受试者的纵向样本 患有活动性结核病以及接受卡介苗疫苗接种的受试者（项目 2）。 CC 将提供肺组织和 来自接受肺部手术的患者的支气管肺泡灌洗标本（BAL），用于临床指征 与 Christian Ottensmeier（英国；项目 3）合作。

PROJECT SUMMARY: Clinical Core The Clinical Core (CC) is an integral part of the LJI HIPC Program. The Core provides leadership and management of all clinical samples and data. This includes ensuring all regulatory documentation is in place for human subjects research both at LJI and at collaborators' institutions, appropriate training of personnel and monitoring all clinical study activities of the HIPC center, managing oversight of internal and external sample collection which includes arranging for regular shipments of samples to LJI, sample storage, clinical data collection, oversight in our specialized donor record administrative system DoRAS, and QC of received samples. The CC ensures that HLA typing is performed on all samples that require it, as well as ensuring it works with the Projects, Sequencing, and Data Management and Analysis Cores to confirm sample integrity and identity throughout the experimental and bioinformatics pipeline process. The overall scientific program will develop a series of immune signatures for antigen-specific T cells responding to a diverse range of respiratory pathogens, such as SARS-CoV-2, common cold coronaviruses, influenza, tuberculosis, pneumococcus, pertussis, and fungi (aspergillus and candida). The success of the entire program is contingent upon successful accrual of high-quality human samples and the associated donor information. Obtaining such samples in sufficient quantity and quality presents specific challenges, because of the proposal's focus on comparison of T cells reactive to different respiratory pathogens, and enrollment of individuals from several, very different, geographical locations. To address these challenges, the CC will use well-developed and validated methods to procure samples (including PBMC, lung tissue, and BAL) from cohorts associated with natural infection, ongoing disease, and vaccination. The cohorts to be used for this program will be obtained from either our well-established in-house LJI Center for Clinical Investigation (CCI) or our experienced collaborators and clinicians that have access to unique cohorts and with whom we have enjoyed fruitful relationships over many years. We are confident in our ability to provide the necessary samples as well as clinical and scientific input to enable the most robust and compelling studies. We will continue recruitment and sample acquisition of already established cohorts, and access previously obtained samples in the context of the SARS-CoV-2 project (Project 1). In addition, we have established long-standing relationships with Drs. Dharshan DeSilva (Sri Lanka), Matt O'Shea (UK), Maria Lerm (Sweden), Cesar Ugarte (Peru), and Richard Silver (USA) that will provide longitudinal samples from subjects with latent TB infection or who are diagnosed with active TB, and from subjects undergoing BCG vaccination (Project 2). The CC will provide lung tissue and bronchoalveolar lavage specimens (BAL) from patients undergoing lung surgery for clinical indications by closely collaborating with Christian Ottensmeier (UK; Project 3).