Core C. Clinical Core/Human subjects

总结-核心C（临床核心） 核心C（临床核心）将支持总体mVACS计划目标，即开发修饰的mRNA疫苗， 通过开发用于CDI人类受试者识别、标本 生物库和元数据收集来研究粪便微生物生态和C.特异性适应性免疫 人类的反应。核心C（临床核心）将负责患者入组、采集、储存和 在生物储存库中处理标本和相关临床数据，并管理向个人的分发 项目此外，将在样本采集后随访纵向临床结局。我们建议 以下具体目标：（1）建立CDI生物储存库和临床数据库， 诊断时的样本和人口统计学数据，包括一系列年龄和合并症;（2）开发 在首次疾病复发时入组的CDI受试者的纵向队列，平行进行深部微生物和 免疫谱分析，与纵向临床结果相关;（3）提供样本和临床元数据 从已建立的生物储存库和队列中提取，以测试和验证体外和动物模型结果 项目1（疫苗开发）、项目2（抗原发现）和项目3（免疫学）。核心 C（临床核心）将促进rCDI的临床特征及其结局与项目1中的结果的相关性 （疫苗开发），项目2（抗原发现）和项目3（免疫学），以及基因组 核心B（基因组学核心）中的发现，以确定和完善可能提高疗效的疫苗靶点。

SUMMARY – CORE C (CLINICAL CORE) Core C (Clinical Core) will support the overall mVACS program goal to develop modified mRNA vaccines to eliminate C.difficile infection (CDI) by developing an infrastructure for CDI human subject identification, specimen biobanking, and metadata collection to study the stool microbial ecology and C. difficile-specific adaptive immune responses in humans. Core C (Clinical Core) will lead enrollment of patients, acquisition, storage, and processing of specimens and associated clinical data in a biorepository and manage the distribution to individual projects. In addition, longitudinal clinical outcomes will be followed after sample collection. We propose the following specific aims: (1) to establish a recurrent CDI biorepository and clinical database, capturing stool samples and demographic data at the time of diagnosis, across a range of ages and comorbidities; (2) to develop a longitudinal cohort of CDI subjects enrolled at first disease recurrence, for in parallel deep microbial and immune profiling, with linkage to longitudinal clinical outcomes; and (3) to provide samples and clinical metadata from the established biorepository and cohort to allow testing and validation of in vitro and animal model findings from Project 1 (Vaccine Development), Project 2 (Antigen Discovery), and Project 3 (Immunology). Core C (Clinical Core) will facilitate correlation of clinical features of rCDI and its outcomes with findings in Project 1 (Vaccine Development), Project 2 (Antigen Discovery), and Project 3 (Immunology), as well as the genomic findings in Core B (Genomics Core) in order to identify and refine vaccine targets that may increase efficacy.