# Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE

> **NIH NIH UM1** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $5,245,366

## Abstract

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B
Supplement Abstract
Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind,
Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of
mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age.
This project supports specific aims 2, 3, and 4 from the Vanderbilt UM1 application and is consistent with the
terms of award. More specifically, the purpose of this activity is to evaluate a variant SARS-CoV-2 vaccine
(mRNA-1273.351) in vaccine-naïve individuals. COVID-19 has led to widespread morbidity and mortality and
though currently authorized vaccines are highly efficacious, the emergence of variant viruses that may escape
disease- and vaccine-induced immunity requires additional vaccines to be evaluated.
 Specific Aim 2: Conduct multi-site and single site research evaluating the safety, efficacy, and
immunogenicity of novel interventions. We propose a multisite response at VUMC (lead), Children’s
Hospital of Philadelphia, Children’s Hospital of Pittsburgh, and Washington University that will enroll
approximately 390 participants.
Specific Aim 3: Evaluate immune responses resulting from natural infection or vaccine
administration. Central to this work will be the evaluation of immune responses to a novel vaccine
candidate.
Specific Aim 4: Train future leaders in vaccinology and clinical trials. Similar to other studies
 conducted for COVID thus far, junior faculty and fellows will be trained in vaccine clinical trials and
 pandemic responsiveness.
This request is to support COVID-19 clinical research, including CoVPN site preparation, trial implementation,
and enrollment of participants in the above COVID-19 clinical research study. Work will include, but is not
limited to, site preparation activities; protocol development/revision; clinical trial activities; pharmacy support;
laboratory processing and storage of samples; laboratory assays; quality oversight; and manuscript
development, as appropriate.
PHS 398/2590 (Rev. 06/09) Page Continuation Format Page

## Key facts

- **NIH application ID:** 10381372
- **Project number:** 3UM1AI148452-02S4
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Clarence Buddy Creech
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $5,245,366
- **Award type:** 3
- **Project period:** 2021-05-14 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10381372

## Citation

> US National Institutes of Health, RePORTER application 10381372, Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVE (3UM1AI148452-02S4). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10381372. Licensed CC0.

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