# CoVPN 3001 -  A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults.

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2022 · $439,437

## Abstract

Project Abstract
This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines
Leadership Operations Center (LOC) for continuing implementation of the first COVID-19 vaccine efficacy trial
“A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy,
Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 (Moderna) Vaccine in Adults Aged 18 Years and
Older.”
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 HVTN has joined 4 other National Institute of
Health (NIH) clinical trial networks to form the CoVPN, an enhanced network dedicated to developing globally
effective vaccines for SARS-CoV-2. Due to its extensive experience implementing HIV vaccine trials, the HIV
Vaccine Trials Network (HVTN) LOC was selected to as the CoVPN vaccine LOC.
This trial, a phase 3, placebo-controlled, double-blinded study will test the efficacy of mRNA-1273 SARS-
CoV-2, a lipid co-formulated messenger ribonucleic acid (mRNA) vaccine encoding the SARS-CoV-2 spike
protein (S), to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from
clinical trial sites across the US, using data analytics to target high risk individuals with a diverse racial and
ethnic profile. In addition, the CoVPN will use accessory community-based sites, staffed by clinical teams
from the home sites and employ mobile clinics to enroll individuals in new high risk settings (e.g., meat
packing plants).
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 at CoVPN laboratories, using validated assays for diagnosis and immune monitoring.
Specific aims of this study are to demonstrate efficacy of mRNA-1273 SARS-CoV-2 to prevent COVID-19, to
evaluate the safety and reactogenicity of 2 injections given 28 days apart, the assess the ability to prevent
infection with SARS-CoV-2, the assess the ability to modify COVID-19 infection, to evaluate viral infection
kinetics, and to evaluate the vaccine induced immune response. A booster injection (3rd dose) will be offered
to participants at least 6 months after the last dose of the primary series. This efficacy trial will tell us much
about the adaptive immune response in persons who receive three doses of an mRNA SARS-CoV-2 S
protein-based vaccine and about their ability to modify the disease course of COVID-19 against current
circulating strains. In addition, It will improve our understanding of the dynamics and duration of these
responses. Lastly, the results of this trial will enable assessment for rare side effects, such as
cardiomyopathy, that wouldn’t otherwise ...

## Key facts

- **NIH application ID:** 10581323
- **Project number:** 3UM1AI068635-17S4
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Peter B. Gilbert
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $439,437
- **Award type:** 3
- **Project period:** 2006-06-29 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10581323

## Citation

> US National Institutes of Health, RePORTER application 10581323, CoVPN 3001 -  A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults. (3UM1AI068635-17S4). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10581323. Licensed CC0.

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