Clinical Core

项目总结：临床核心 临床核心（CC）是LJI重债穷国计划的组成部分。核心提供领导， 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和合作机构的人类受试者研究，适当的人员培训， 监测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，包括安排定期向LJI运送样本、样本储存、临床数据 收集，在我们的专业供体记录管理系统DoRAS中监督，并对收到的样本进行QC。 CC确保对所有需要HLA分型的样本进行HLA分型，并确保其与 项目、测序、数据管理和分析核心，以确认样品完整性和同一性 整个实验和生物信息学管道过程。 整个科学计划将开发一系列针对抗原特异性T细胞的免疫特征 对多种呼吸道病原体，如SARS-CoV-2，普通感冒冠状病毒， 流感、肺结核、肺炎球菌、百日咳和真菌（曲霉菌和念珠菌）。整个的成功 该计划取决于高质量的人类样本和相关供体的成功积累 信息.获得足够数量和质量的此类样本提出了具体挑战，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，以及招募 来自不同地理位置的个体。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）的成熟且经验证的方法 与自然感染、持续疾病和疫苗接种有关。用于该计划的队列将 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，他们可以接触到独特的队列， 多年来卓有成效的关系。我们也有信心提供所需的样品 作为临床和科学输入，以实现最强大和最引人注目的研究。我们将继续招聘 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，我们已与陈博士建立长期合作关系。 达尔尚·德席尔瓦（斯里兰卡）、马特·奥谢（英国）、玛丽亚·利特尔（瑞典）、塞萨尔·乌加特（秘鲁）和理查德· 银（美国），将提供来自潜伏性TB感染受试者或诊断为TB的受试者的纵向样本 活动性TB患者和接受BCG疫苗接种的受试者（项目2）。CC将提供肺组织， 来自接受肺手术的患者的支气管肺泡灌洗标本（BAL）， 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).