# Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required)-DMID 21-0012

> **NIH NIH UM1** · CINCINNATI CHILDRENS HOSP MED CTR · 2021 · $1,283,750

## Abstract

PROJECT SUMMARY
As a VTEU for nearly 25 years, we have provided the scientific, clinical, administrative, and organizational
structure to support implementation of clinical trials and studies for the Division of Microbiology and Infectious
Diseases (DMID) including respiratory infections, enteric diseases, sexually transmitted infections and
neglected tropical diseases. Also, we are recognized experts in the area of human challenge infection models
(CHIMs) of enteric and respiratory pathogens. Additionally we repeatedly have demonstrated the ability to
provide surge capacity to address infectious disease outbreaks as evidenced by our responses to the testing of
H5N1 and novel H1N1 influenza vaccines (for which we received a personal letter from Dr Anthony Fauci). To
further expand the capabilities of our Unit; we have added expertise in epidemiology and vaccine
effectiveness. We consistently have met or exceed enrollment goals and routinely have over 90% of our
subjects complete the study. We consistently have exceeded contractual obligations, including rapid
recruitment of subjects spanning the age spectrum including pregnant women. We have provided outstanding
leadership of multi-center studies and have been excellent collaborators on studies led by other VTEU sites.
We have developed investigator initiated trials and have assisted in the development of trials initiated by DMID.
We also have undertaken vaccine projects incorporating systems biology to more deeply understand correlates
of vaccine-induced immunity. We are extremely excited to continue as a VTEU, collaborating with the IDCRC,
the Leadership Group, NIAID, and other Infectious Diseases experts under this NIAID Cooperative Agreement.
The main focus of the parent grant is to provide funding to assemble and maintain the team needed to perform
clinical trials. The supplemental funding will provide the resources needed to conduct COVID-19 vaccine trials.
It is projected that with the supplemental funding, we will recruit, enroll and retain 90 participants over the 2
year period of the study.

## Key facts

- **NIH application ID:** 10402467
- **Project number:** 3UM1AI148372-02S3
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Robert Wilson Frenck
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,283,750
- **Award type:** 3
- **Project period:** 2021-07-20 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10402467

## Citation

> US National Institutes of Health, RePORTER application 10402467, Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required)-DMID 21-0012 (3UM1AI148372-02S3). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10402467. Licensed CC0.

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