# Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0004

> **NIH NIH UM1** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $658,548

## Abstract

Program Director/Principal Investigator (Last, First, Middle): Creech, Clarence B
Supplement Abstract
Observational, Prospective Cohort Study of the Immunogenicity and Safety of SARS-CoV-2 Vaccines
Administered during Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants.
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 the immunogenicity and safety of
SARS-CoV-2 vaccines administered during pregnancy or post-partum and evaluate antibody transfer.
 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:** 10404421
- **Project number:** 3UM1AI148452-02S6
- **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:** $658,548
- **Award type:** 3
- **Project period:** 2021-08-10 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10404421

## Citation

> US National Institutes of Health, RePORTER application 10404421, Vanderbilt Vaccine and Treatment Evaluation Unit - DMID 21-0004 (3UM1AI148452-02S6). Retrieved via AI Analytics 2026-09-25 from https://api.ai-analytics.org/grant/nih/10404421. Licensed CC0.

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