# University of Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012

> **NIH NIH UM1** · UNIVERSITY OF WASHINGTON · 2021 · $1,259,301

## Abstract

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), causative agent of the coronavirus
disease of 2019 (COVID-19) pandemic, has infected over 126 million people worldwide and resulted in over
2.7 million deaths, including > 548,000 in the United States (March 27, 2021, WHO; www.who.int). Multiple
Phase 3 efficacy trials of SARS-CoV-2 vaccine constructs are underway or in long-term follow-up in the U.S,
and these studies have supported 3 Emergency Use Authorizations (EUAs) for COVID vaccines. The
emergence of variant strains has raised concerns about the breadth of immunity and protection achieved by
the current vaccines. WHO SAGE and CDC ACIP have identified the safety and immunogenicity of mixed
schedules as a critical and immediate research priority to inform policy on the use of mixed schedules.
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 is a critical piece of
information needed to inform public health decisions. The heterologous boost strategy will also provide an
opportunity to thoroughly evaluate innate, cellular, and humoral immune responses elicited from the multiple
prime boost combinations using very similar immunogens, utilizing mRNA, adenovirus- vectored, and protein-
based platforms. As new vaccines are manufactured to emerging variants, these foundational data will be key
to the evaluation of future variant and heterologous prime-boost strategies. This phase 1/2 clinical trial will
evaluate the safety and immunogenicity of different heterologous delayed doses (boosts) in those who
received an EUA vaccine (either prior to participation in this trial, or as part of this trial).

## Key facts

- **NIH application ID:** 10410301
- **Project number:** 3UM1AI148573-02S4
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Raymond Scott McClelland
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,259,301
- **Award type:** 3
- **Project period:** 2021-08-24 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410301

## Citation

> US National Institutes of Health, RePORTER application 10410301, University of Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012 (3UM1AI148573-02S4). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10410301. Licensed CC0.

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