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A Study of Ad26.COV2.S for th...

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

Last Updated: 2025-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2023-03-31

Brief Summary

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The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

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Detailed Description

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Conditions

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Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ad26.COV2.S

Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.

Group Type EXPERIMENTAL

Ad26.COV2.S

Intervention Type BIOLOGICAL

Ad26.COV2.S will be administered at a single dose of 5\*10\^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.

Placebo

Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\*10\^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.

Group Type EXPERIMENTAL

Ad26.COV2.S

Intervention Type BIOLOGICAL

Ad26.COV2.S will be administered at a single dose of 5\*10\^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.

Placebo

Intervention Type OTHER

Participants will receive Placebo.

Interventions

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Ad26.COV2.S

Ad26.COV2.S will be administered at a single dose of 5\*10\^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.

Intervention Type BIOLOGICAL

Placebo

Participants will receive Placebo.

Intervention Type OTHER

Other Intervention Names

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JNJ-78436735 Ad26COVS1

Eligibility Criteria

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Inclusion Criteria

* Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
* All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
* Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 \[COVID 19\] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires

Exclusion Criteria

* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
* Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
* Participant previously received a coronavirus vaccine
* Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

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Synexus Clinical Research US Inc

Birmingham, Alabama, United States

Site Status

University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Alabama Vaccine Research Clinic at UAB

Birmingham, Alabama, United States

Site Status

Optimal Research

Huntsville, Alabama, United States

Site Status

Synexus Clinical Research US Inc

Glendale, Arizona, United States

Site Status

VA Medical Center

Phoenix, Arizona, United States

Site Status

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Site Status

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States

Site Status

Synexus Clinical Research US Inc

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Ark Clinical Research

Long Beach, California, United States

Site Status

Anthony Mills Medical, Inc

Los Angeles, California, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

Site Status

UCSD Antiviral Research Center AVRC

San Diego, California, United States

Site Status

Wr McCr Llc

San Diego, California, United States

Site Status

VA Medical Center

San Francisco, California, United States

Site Status

Childrens Hospital Colorado

Aurora, Colorado, United States

Site Status

Rocky Mountain Regional VA Medical Center

Denver, Colorado, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

North Florida South Georgia Veteran Health System

Gainesville, Florida, United States

Site Status

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Site Status

Research Centers of America, LLC

Hollywood, Florida, United States

Site Status

Suncoast Research Group

Miami, Florida, United States

Site Status

University of Miami - Miller School of Medicine

Miami, Florida, United States

Site Status

Orlando Immunology Center

Orlando, Florida, United States

Site Status

Advent Health Orlando

Orlando, Florida, United States

Site Status

Synexus Clinical Research US Inc

Orlando, Florida, United States

Site Status

Synexus Clinical Research US Inc

Pinellas Park, Florida, United States

Site Status

James A Haley VA Hospital GNS

Tampa, Florida, United States

Site Status

Synexus Clinical Research US Inc

The Villages, Florida, United States

Site Status

Emory University of Medicine

Atlanta, Georgia, United States

Site Status

The Hope Clinic at Emory University

Decatur, Georgia, United States

Site Status