# Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: CoVPN 3004

> **NIH NIH UM1** · UNIVERSITY OF MARYLAND BALTIMORE · 2021 · $509,201

## Abstract

Project Summary/Abstract
The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health
(CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts
for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics,
therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is
uniquely poised to accomplish this goal. CVD’s expert and accomplished investigative team has
complementary skill sets in all areas necessary to address the NIAID priority areas, with established
management plans to effectively allocate work and conduct multiple projects simultaneously. In the past 17
months, a key area of interest at NIAID has been discovery of safe and effective protective measures,
including vaccines, for persons at risk of COVID-19. This proposal describes the implementation of a critical
protocol in that arena, namely the Pediatric expansion of the phase 3 pivotal efficacy study of the Novavax
recombinant spike protein vaccine with M Matrix adjuvant. The project’s primary objectives are (1) to evaluate
the efficacy of a 2-dose regimen of SARS-CoV-2 rS adjuvanted with Matrix-M1 compared to placebo against
PCR-confirmed symptomatic COVID-19 illness diagnosed ≥ 7 days after completion of the second injection in
the initial set of vaccinations of adolescent participants 12 to < 18 years of age; and (2) to describe the
safety experience for the vaccine versus placebo in adolescent participants (12 to <18 years of age) based on
solicited short-term reactogenicity by toxicity grade for 7 days following each vaccination (Days 0 and 21) after
the initial set of vaccinations. Multiple additional objectives are also being evaluated. The design is a Phase 3,
randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of
SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants ≥ 18 years of age (Adult Main Study) with a
Pediatric Expansion (This proposal is for the Pediatric Expansion). In the Pediatric Expansion, adolescent
participants 12 to 17 years of age will be enrolled without stratification. Participants are followed for 2 years for
safety, tolerability, efficacy, and immune responses. The expected sample size will be 3000 adolescents: 2000
will receive vaccine first and 1000 will receive placebo first. After 6 months, there will be a double-blind cross
over. This study is expected to contribute the data necessary to allow for authorization of this vaccine in 12 to
17 year-olds in the US.

## Key facts

- **NIH application ID:** 10410208
- **Project number:** 3UM1AI148689-02S4
- **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:** $509,201
- **Award type:** 3
- **Project period:** 2021-07-14 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410208

## Citation

> US National Institutes of Health, RePORTER application 10410208, Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: CoVPN 3004 (3UM1AI148689-02S4). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10410208. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*