# CoVPN 3008 - Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2022 · $14,844,618

## 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
“Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2
Variants of Concern.”
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, observer-blinded, placebo-controlled, crossover-vaccination study will test the efficacy of
the COVID-19 ancestral strain mRNA vaccine in preventing COVID-19 disease regardless of severity,
and preventing COVID-19 severe disease in people who are at risk for severe COVID-19 in areas of the world
where the prevalence of the SARS-CoV-2 1.351 strain is substantial.
The trial has been designed to provide as rapid assessment of efficacy as possible in regions of the world
where local access to effective vaccines are limited. Subjects will be randomized in a 1:1 ratio to receive
immediate or deferred vaccine. The blinded cross-over is expected to take place when vaccine benefit is
declared based on at least 50 primary COVID-19 endpoints, anticipated to be accrued approximately 3
months post-trial start. 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 COVID-19 mRNA (Moderna mRNA-1273) vaccine
to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at
risk of severe COVID-19; to assess vaccine efficacy of COVID-19 mRNA vaccine to prevent severe COVID-19
starting 14 days after dose 2 in adults who are at risk of severe COVID-19; and to assess safety and
tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19.
This efficacy trial will tell us much about ability of an mRNA vaccine against the ancestral Wuhan strain of
SARS-CoV-2 to protect individuals exposed to divergent strains, and in particular 1.351 first predominant
in South Africa. 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 in parts of the world where alternative strains continue to proliferate. Lastly, the results of this
trial will ...

## Key facts

- **NIH application ID:** 10582009
- **Project number:** 3UM1AI068635-17S1
- **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:** $14,844,618
- **Award type:** 3
- **Project period:** 2006-06-29 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10582009

## Citation

> US National Institutes of Health, RePORTER application 10582009, CoVPN 3008 - Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern (3UM1AI068635-17S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10582009. Licensed CC0.

---

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