# Kaiser Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012

> **NIH NIH UM1** · KAISER FOUNDATION RESEARCH INSTITUTE · 2021 · $2,014,564

## Abstract

This Supplemental Funding application requests funding for the Kaiser Washington Vaccine and Treatment
Evaluation Unit (VTEU) to function as a clinical site for DMID study 21-0012, a Phase 1/2 study of delayed
heterologous SARS-CoV-2 vaccine dosing (boost) after receipt of EUA vaccines. This 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).
Since the 1960s the VTEUs have conducted trials of vaccines and therapeutic candidates for infectious
diseases of public health importance (other than HIV) including, for example, influenza, malaria, smallpox,
anthrax, and pneumococcal infection. Kaiser Washington has been continuously funded as a VTEU site since
2007, and in 2019 was awarded a seven-year cooperative agreement as one of ten VTEU sites in the newly
formed NIAID Infectious Diseases Clinical Research Consortium (IDCRC).
In 2020, the NIH and the IDCRC responded to the COVID-19 pandemic by launching the first trial (20-0003) of
a candidate COVID-19 vaccine (mRNA-1273), an mRNA vaccine co-developed by the NIH Vaccine Research
Center and Moderna, Inc, in March 2020. The Kaiser Washington VTEU was originally the sole site for that trial
which was later expanded in terms of enrollment and sites, to also include the Emory University School of
Medicine VTEU and the NIH Vaccine Research Center sites. mRNA-1273 has been granted Emergency Use
Authorization, as has an mRNA vaccine from Pfizer and an adenovirus-vectored vaccine from Janssen.
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.

## Key facts

- **NIH application ID:** 10414676
- **Project number:** 3UM1AI148373-02S5
- **Recipient organization:** KAISER FOUNDATION RESEARCH INSTITUTE
- **Principal Investigator:** LISA A JACKSON
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,014,564
- **Award type:** 3
- **Project period:** 2021-08-12 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10414676

## Citation

> US National Institutes of Health, RePORTER application 10414676, Kaiser Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012 (3UM1AI148373-02S5). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10414676. Licensed CC0.

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