# Core C. Clinical Core/Human subjects

> **NIH NIH U19** · UNIVERSITY OF PENNSYLVANIA · 2024 · $215,035

## Abstract

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.

## Key facts

- **NIH application ID:** 10792892
- **Project number:** 5U19AI174998-02
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Brendan Joseph Kelly
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $215,035
- **Award type:** 5
- **Project period:** 2023-03-01 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10792892

## Citation

> US National Institutes of Health, RePORTER application 10792892, Core C. Clinical Core/Human subjects (5U19AI174998-02). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10792892. Licensed CC0.

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