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Core C. Clinical Core/Human subjects

核心 C. 临床核心/人类受试者

基本信息

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
项目类别：
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

项目摘要

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）