# CoVPN 3004 - A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine - LC3

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2022 · $4,637,125

## Abstract

Project Abstract
This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership
Operations Center (LOC) for implementation of the COVID-19 vaccine efficacy trial entitled “A Phase 3,
Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity
of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M™ Adjuvant
in Adult Participants ≥ 18 years.”
With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in
SARS-CoV-2 infected individuals. Addressing this gap, the National Institutes of Health (NIH) led rapid
constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of
physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries dedicated to
developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global
HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC
for CoVPN vaccine trials.
This Phase 3, placebo-controlled, observer-blinded study will test the efficacy, safety and immunogenicity of
SARS CoV-2 rS, a nanoparticle vaccine intended for administration with Matrix-M adjuvant, to modify COVID-
19 disease in adults 18 years of age and older. Participants will be recruited from clinical trial sites across the
US and globally using data analytics to target high risk individuals with a diverse racial and ethnic profile.
Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be
monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who progress
to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be done using
qualified and validated assays for diagnosis and immune monitoring.
Specific aims of this study are to demonstrate efficacy of SARS-CoV-2 rS vaccine to prevent SARS-CoV-2
infection and COVID-19 disease; to evaluate its effect across race, ethnicity, high-risk vs. low-risk demographic
groups; to evaluate binding and neutralizing antibody responses; to evaluate the durability of immune responses;
to assess the vaccine safety; to assess all-cause mortality in the two groups; and to perform health economics
and outcomes research (HEOR). This efficacy trial will tell us much about the adaptive immune response in
persons who receive a SARS-CoV-2 rS nanoparticle-based vaccine and about their ability to modify the disease
course of COVID-19. In addition, it will improve our understanding of the dynamics and duration of these immune
responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody
interventions. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as
to mod...

## Key facts

- **NIH application ID:** 10570702
- **Project number:** 3UM1AI068618-17S4
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Margaret Juliana McElrath
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $4,637,125
- **Award type:** 3
- **Project period:** 2006-06-29 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10570702

## Citation

> US National Institutes of Health, RePORTER application 10570702, CoVPN 3004 - A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine - LC3 (3UM1AI068618-17S4). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10570702. Licensed CC0.

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