# Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0012

> **NIH NIH UM1** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $1,046,814

## Abstract

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B
Supplement Abstract
A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA
Vaccines.
This project supports specific aims 2, 3, and 4 from the Vanderbilt UM1 application and is consistent with the
terms of award. More specifically, this activity is designed to gain knowledge of the safety, tolerability, and
immunogenicity of a boost vaccine using a heterologous platform with the homologous or variant spike lineage
administered after an EUA primary dosing
 Specific Aim 2: Conduct multi-site and single site research evaluating the safety, efficacy, and
immunogenicity of novel interventions. We propose a single site at Children’s Hospital of Philadelphia
that will evaluate the immune response to COVID vaccines in pregnancy
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 COVID 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-related clinical studies
 and pandemic responsiveness.
This request is to support COVID-19 clinical research, including site preparation, study 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 study activities; laboratory processing and
storage of samples; quality oversight; and manuscript development, as appropriate.
PHS 398/2590 (Rev. 06/09) Page Continuation Format Page

## Key facts

- **NIH application ID:** 10405373
- **Project number:** 3UM1AI148452-02S5
- **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:** $1,046,814
- **Award type:** 3
- **Project period:** 2021-07-07 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10405373

## Citation

> US National Institutes of Health, RePORTER application 10405373, Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0012 (3UM1AI148452-02S5). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10405373. Licensed CC0.

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