# University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric Study

> **NIH NIH UM1** · UNIVERSITY OF ROCHESTER · 2021 · $1,144,400

## Abstract

The Vaccine and Treatment Evaluation Units (VTEUs) are a critical resource for the NIAID Infectious Diseases
Clinical Research Consortium to conduct clinical research and trials to evaluate vaccines, preventive biologics,
therapeutics, diagnostics, predictive markers, and devices for the treatment and prevention of infectious
diseases in people of all ages and risk categories. The VTEU network sites must flexible and respond to
emerging threats and changing NIAID priorities. To this end, the University of Rochester VTEU (UR VTEU) will
collaborate with NIAID and the VTEU leadership group (VTEU LG) to address and prioritize initiatives for
infectious diseases such as respiratory, enteric, sexually transmitted infections and antibiotic resistant
organisms as well as maintain flexibility to switch focus to emerging threats as the need arises. The University
of Rochester is fortunate to enjoy a community with a very positive attitude towards clinical research and
collaborative relationships between the major healthcare providers in the city providing access to all the
hospitals, clinics and practices in the area. The UR VTEU offers a very experienced administrative and clinical
group with a proven track record of successful multicenter clinical trial work. With the support of the VTEU LG,
the UR VTEU will be well positioned to develop as well as implement concepts and projects that address
important NIAID priorities and formulate best practices, efficiencies and standard operating procedures among
VTEU sites. UR VTEU investigators have expertise in adult and pediatric clinical research as well as
recruitment of vulnerable populations into clinical trials and thus can anticipate successful recruitment of young
and older adults, infants, young children and adolescents, and pregnant women. Additionally, the close
relationship of the Monroe County Health Department with the University provides access to patients with
sexually transmitted diseases for study participation. We will provide capacity to perform phase 1-3 clinical
trials and pharmacokinetic studies as well as surge capacity in terms of personnel and clinical research sites to
rapidly respond to urgent NIAID demands. Importantly, our investigators have experience conducting challenge
and isolation studies and can provide VTEU facilities for such projects. Our research laboratory expertise will
provide the VTEU network with a variety of state of the art technologies to interrogate the host response to
infection and immunization as well as develop a deeper understanding of pathogenesis for many infectious
diseases. Specifically, core faculty have expertise in a wide range of novel immunologic assays as well as
transcriptional and microbiome analysis. In addition, the UR VTEU will provide research opportunities and
education for junior faculty to train the next generation of physician scientists. All clinical trials will adhere to
NIAID/NIH requirements and comply with Good Clinical Practice. In su...

## Key facts

- **NIH application ID:** 10380976
- **Project number:** 3UM1AI148450-02S2
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Angela Ramona Branche
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,144,400
- **Award type:** 3
- **Project period:** 2021-05-01 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10380976

## Citation

> US National Institutes of Health, RePORTER application 10380976, University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric Study (3UM1AI148450-02S2). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10380976. Licensed CC0.

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