# Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site:21-0011

> **NIH NIH UM1** · UNIVERSITY OF MARYLAND BALTIMORE · 2021 · $11,669,935

## Abstract

Project Summary
The primary goal of current COVID-19 vaccine trials is to measure vaccine efficacy (VE) against clinically
significant infection. However, on a population level, vaccine efficacy against all infection, including
asymptomatic or very mildly symptomatic infection, is an important endpoint. This proposal outlines an ancillary
swab study to the Novavax Phase 3 SARS-CoV-2 vaccine trial (PREVENT-19) to address these knowledge
gaps.
With the global SARS-CoV-2 pandemic, we recognize a significant need for vaccines that not only modify
COVID-19 in SARS-CoV-2 infected individuals but also reduce infection/transmission regardless of
symptomatology. In this study, participants will self-swab twice weekly starting at or shortly after their second
dose of either SARS-CoV-2 rS/M1 or placebo. These swabs will be tested for SARS-CoV-2 by RT-PCR.
Specific Aims of this study are to estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against infection, to
estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against asymptomatic/very mildly symptomatic infection, to
determine the sequence of breakthrough SARS-CoV-2 infections, to estimate the vaccine efficacy on duration
of infection, to estimate the vaccine efficacy against SARS-CoV-2 viral load as a proxy of transmission, and to
explore whether observed vaccine efficacy against COVID-19 illness reflects a transition from symptomatic into
asymptomatic infections versus an absolute reduction in all SARS-CoV-2 infections.
This ancillary swab study will tell us much about the ability of SARS-CoV-2 rS/M1 to reduce infection regardless
of symptomatology. In addition, it will provide important information on the ability of the vaccine to reduce duration
of infection and transmission.

## Key facts

- **NIH application ID:** 10414457
- **Project number:** 3UM1AI148689-02S6
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Karen L. Kotloff
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $11,669,935
- **Award type:** 3
- **Project period:** 2021-08-11 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10414457

## Citation

> US National Institutes of Health, RePORTER application 10414457, Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site:21-0011 (3UM1AI148689-02S6). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10414457. Licensed CC0.

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