Core C. Clinical Core/Human subjects

核心 C. 临床核心/人类受试者

• 批准号: 10625576
• 负责人: Brendan Joseph Kelly
• 金额: $ 20.88万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10625576
• 关键词: Academic Medical Centers; Adult; Affect; Age; Animal Model; Antigens; Biological Assay; Biological Specimen database; Blood specimen; Childhood; Clinical; Clinical Data; Clostridium difficile; Colitis; Collaborations; Collection; Communities; Data; Development; Diagnosis; Disease; Ecology; Elderly; Enrollment; Ensure; Feces; Genomics; Goals; Health system; Healthcare; Human; Hypotension; Ileus; Immune; Immune response; Immunologics; Immunology; In Vitro; Incidence; Individual; Infection; Infection prevention; Infrastructure; Lead; Longitudinal cohort; Megacolon; Metadata; Microbe; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Pediatric Hospitals; Pediatric cohort; Pennsylvania; Philadelphia; Play; Population; Population Heterogeneity; Predictive Factor; Public Health; RNA vaccine; Recurrence; Recurrent disease; Research Project Grants; Risk; Risk Factors; Role; Sampling; Severities; Severity of illness; Shock; Specimen; Specimen Handling; Symptoms; Testing; Time; Universities; Vaccination; Vaccine Antigen; Vaccines; Validation; Work; adaptive immune response; age group; biobank; clinical database; clinically relevant; cohort; comorbidity; fecal transplantation; gut microbiota; human subject; innovation; microbial; microorganism interaction; mortality; novel; novel vaccines; older patient; participant enrollment; patient population; prevent; programs; recurrent infection; risk mitigation; sample collection; stool sample; success; vaccination strategy; vaccine development

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.

摘要 - 核心C（临床核心） 核心C（临床核心）将支持总体MVAC计划目标，以开发经过修改的mRNA疫苗 通过开发用于CDI人类受试者鉴定的基础架构来消除缺乏的感染（CDI） 生物群和元数据收集，以研究粪便微生物生态学和艰难梭菌特异性适应性免疫 人类的回应。核心C（临床核心）将领导患者的招生，收购，存储和 在生物座席中处理标本和相关的临床数据，并管理对个人的分布 项目。此外，样本收集后将遵循纵向临床结果。我们建议 以下具体目的：（1）建立一个经常性的CDI生物座和临床数据库，捕获凳子 诊断时，跨多种年龄和合并症的样品和人口统计数据； （2）发展 CDI受试者的纵向队列在第一次疾病复发中，因为在平行的深层微生物和 免疫分析，与纵向临床结果有联系； （3）提供样品和临床元数据 从已建立的生物座位和队列中，允许对体外和动物模型发现进行测试和验证 摘自项目1（疫苗开发），项目2（抗原发现）和项目3（免疫学）。核 C（临床核心）将促进RCDI临床特征及其结果与项目1中的发现相关 （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（基因组核心）中的发现是为了识别和完善可能提高效率的疫苗靶标。