A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

In brief

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.

Key facts

Study ID

NCT04614948

Run by

Janssen Vaccines & Prevention B.V.

People needed

31835

Starts

2020-11-12

Expected to finish

2023-06-18

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)

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 has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients
• 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 within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational 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

• Hope Research Institute — 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
• Woodland International Research Group — Little Rock, Arkansas, United States
• Synexus Clinical Research US Inc — Cerritos, California, United States
• eStudySite — Chula Vista, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Anthony Mills Medical, Inc — Los Angeles, California, United States
• Benchmark Research — Sacramento, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Paradigm Clinical Research Centers, Inc. — Wheat Ridge, Colorado, United States
• JEM Research LLC — Atlantis, Florida, United States
• Prestige Clinical Research Center, Inc. — Coral Gables, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
• Health Awareness inc. — Jupiter, Florida, United States
• Altus Research, Inc — Lake Worth, Florida, United States
• Compass Research, Melbourne — Melbourne, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• Behavioral Clinical Research , Inc — North Miami, Florida, United States
• Clinical NeuroScience Solutions Inc — Orlando, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Achieve Clinical Research, LLC — Vestavia Hills, Alabama, United States

Full record on ClinicalTrials.gov

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