# CoVPN 3003 A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older SDMC

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2021 · $18,322,345

## 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 Randomized,
Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the
Prevention of SARS-CoV-2-mediated COVID-19 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 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 64 United States (US) and 55 international clinical trial sites in 15 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, double-blinded study will test the efficacy of Ad26.COV2.S, a recombinant,
replication-incompetent adenovirus type 26 (Ad26) vector constructed to encode the severe acute respiratory
syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein to modify COVID-19 disease in adults 18 year of age
and older. Participants will be recruited from clinical trial sites across the US, Latin America and South
Africa 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 Ad26.COV2.S to prevent COVID-19, to evaluate the
safety, tolerability and reactogenicity of one intramuscular (IM) injection of 1x1011 viral particles (vp) or placebo,
to assess the ability to prevent infection with SARS-CoV-2, to assess the ability to modify COVID-19 disease,
to assess the ability to prevent emergency room visits, and to evaluate the binding and neutralizing antibody
responses. This efficacy trial will tell us much about the adaptive immune response in persons who receive a
SARS-CoV-2 S protein-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 ...

## Key facts

- **NIH application ID:** 10320660
- **Project number:** 3UM1AI068635-15S1
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Peter B. Gilbert
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $18,322,345
- **Award type:** 3
- **Project period:** 2020-12-19 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10320660

## Citation

> US National Institutes of Health, RePORTER application 10320660, CoVPN 3003 A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older SDMC (3UM1AI068635-15S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10320660. Licensed CC0.

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