Clinical Core

项目摘要：临床核心 临床核心(CC)是LJI重债穷国计划不可或缺的一部分。核心提供领导力和 管理所有临床样本和数据。这包括确保所有法规文件都已就位 在LJI和合作者的机构进行人体研究，适当的人员培训和 监督HIPC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本运送到LJI、样本存储、临床数据 收集、监督我们专门的捐赠者记录管理系统DORA，以及对收到的样本进行质量控制。 CC确保对所有需要它的样本执行人类白细胞抗原分型，并确保它与 项目、测序、数据管理和分析核心，以确认样本完整性和身份 在整个实验和生物信息学管道过程中。 整个科学计划将为抗原特异性T细胞开发一系列免疫标志 应对各种呼吸道病原体，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(曲霉和念珠菌)。整个项目的成功 该计划取决于成功获得高质量的人体样本和相关的捐赠者 信息。以足够的数量和质量获得这种样本是一项特殊的挑战，因为 该提案的重点是比较T细胞对不同呼吸道病原体的反应，以及登记 来自几个非常不同的地理位置的人。为了应对这些挑战，消委会将使用 从队列中获取样本(包括PBMC、肺组织和BAL)的成熟和有效的方法 与自然感染、持续疾病和疫苗接种有关。将用于该计划的队列将 可从我们完善的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，他们可以接触到独特的队列，并与我们一起享受 多年来卓有成效的关系。我们相信我们也有能力提供必要的样品 作为临床和科学投入，以支持最有力和最有说服力的研究。我们将继续招聘 以及已经建立的队列的样本获取，以及在上下文中访问先前获得的样本 SARS-CoV-2项目(项目1)。此外，我们还与杜克博士建立了长期的合作关系。 达山·德席尔瓦(斯里兰卡)、马特·奥谢(英国)、玛丽亚·勒姆(瑞典)、塞萨尔·乌加特(秘鲁)和理查德 Silver(美国)，将提供来自潜在结核病感染者或确诊患者的纵向样本 活动性结核病患者和接受卡介苗接种的受试者(项目2)。CC将提供肺组织和 密切观察肺手术患者支气管肺泡灌洗标本的临床指征 与克里斯蒂安·奥滕斯迈尔(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).