Core C. Clinical Core/Human subjects

摘要-核心C(临床核心) CORE C(临床核心)将支持mVACS计划的总体目标，以开发经修改的mRNA疫苗以 通过开发艰难梭菌感染(CDI)人类受试者识别、标本识别的基础设施来消除CDI 生物库和元数据收集，以研究粪便微生物生态和艰难梭菌特异性适应性免疫 人类的反应。核心C(临床核心)将领导患者登记、获取、存储和 在生物存储库中处理样本和相关临床数据，并管理将其分发给个人 项目。此外，在样本收集后将跟踪纵向临床结果。我们建议 具体目标如下：(1)建立经常性CDI生物信息库和临床数据库，捕获粪便 诊断时的样本和人口学数据，涵盖不同年龄和合并症；(2)发展 在首次疾病复发时登记的CDI受试者的纵向队列，平行的深部微生物和 免疫分析，与纵向临床结果相联系；以及(3)提供样本和临床元数据 来自已建立的生物信息库和队列，以允许测试和验证体外和动物模型的发现 来自项目1(疫苗开发)、项目2(抗原发现)和项目3(免疫学)。堆芯 C(临床核心)将促进将RCDI的临床特征及其结果与项目1中的结果相关联 (疫苗开发)，项目2(抗原发现)，项目3(免疫学)，以及基因组 在核心B(基因组核心)中的发现，以确定和改进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.