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

> **NIH NIH UM1** · CINCINNATI CHILDRENS HOSP MED CTR · 2020 · $6,390,081

## Abstract

PROJECT SUMMARY
Throughout history, infectious diseases have been, and continue to be, a leading cause of morbidity and
mortality throughout the world. While all ages are affected by infectious diseases, the ends of the spectrum of
life (young children and elderly) are particularly vulnerable. Thus, the prevention and treatment of infectious
diseases through the development of vaccines, therapeutics, devices and diagnostics is a critical global
priority.
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.

## Key facts

- **NIH application ID:** 10238529
- **Project number:** 3UM1AI148372-01S1
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Robert Wilson Frenck
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $6,390,081
- **Award type:** 3
- **Project period:** 2020-08-24 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10238529

## Citation

> US National Institutes of Health, RePORTER application 10238529, Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) (3UM1AI148372-01S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10238529. Licensed CC0.

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