A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Completed · Phase 3 · Has a placebo group
Conditions studied: Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
In brief
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.
Key facts
- Study ID
- NCT04505722
- Run by
- Janssen Vaccines & Prevention B.V.
- People needed
- 44325
- Starts
- 2020-09-07
- Expected to finish
- 2023-03-31
- Last updated by the study team
- 2025-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- Alabama Vaccine Research Clinic at UAB — Birmingham, Alabama, United States
- Optimal Research — Huntsville, Alabama, United States
- Synexus Clinical Research US Inc — Glendale, Arizona, United States
- VA Medical Center — Phoenix, Arizona, United States
- Central Phoenix Medical Clinic — Phoenix, Arizona, United States
- Quality of Life Medical & Research Center, LLC — Tucson, Arizona, United States
- Synexus Clinical Research US Inc — Tucson, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
- Anaheim Clinical Trials, LLC — Anaheim, California, United States
- Ark Clinical Research — Long Beach, California, United States
- Anthony Mills Medical, Inc — Los Angeles, California, United States
- Stanford University Medical Center — Palo Alto, California, United States
- UCSD Antiviral Research Center AVRC — San Diego, California, United States
- Wr McCr Llc — San Diego, California, United States
- VA Medical Center — San Francisco, California, United States
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Rocky Mountain Regional VA Medical Center — Denver, Colorado, United States
- Avail Clinical Research, LLC — DeLand, Florida, United States
- North Florida South Georgia Veteran Health System — Gainesville, Florida, United States
- Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
- Research Centers of America, LLC — Hollywood, Florida, United States
- Suncoast Research Group — Miami, Florida, United States
- Synexus Clinical Research US Inc — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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