# 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 LOC

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2022 · $5,663,427

## Abstract

NOSI: NOT-AI-20-034
FOA: PA-20-135 – Emergency Competitive Revision to Existing NIH Awards
Activity Code/Award: UM1/A1068614-15 (parent award)
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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 a
SARS CoV-2 rS, a nanoparticle vaccine administered with Matrix-M adjuvant administered in two doses 21 days
apart, to modify COVID-19 disease in adults 18 years of age and older. Participants who receive placebo during
original randomization will receive vaccine at unblinding. All participants will be offered a 3rd booster dose no
than 8 months after completing the original regimen. 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 re...

## Key facts

- **NIH application ID:** 10580569
- **Project number:** 3UM1AI068614-17S6
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Dan H. Barouch
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $5,663,427
- **Award type:** 3
- **Project period:** 2006-06-29 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10580569

## Citation

> US National Institutes of Health, RePORTER application 10580569, 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 LOC (3UM1AI068614-17S6). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10580569. Licensed CC0.

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