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.
The aim of the COVID-19 vaccine clinical development program is to develop a safe and
effective vaccine for the prevention of COVID-19. Ad26.COV2.S, a COVID-19 vaccine based on a
human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory
syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. The study
will consist of: a screening phase (up to 28 days), study period (60-week), and a long-term
follow-up period (1 additional year). The total study duration will be maximum 2 years and 3
months for the participants. Assessments for efficacy (COVID-19 signs and symptoms, etc.),
immunogenicity (such as humoral immune responses), and safety (such as adverse events [AEs]
monitoring) will be performed throughout the study.
Biological: Ad26.COV2.S
Ad26.COV2.S vaccine will be administered on Day 1 and Day 57 in the double-blind phase. At unblinding visit Ad26.COV2.S vaccine will be administered to participants at Day 57 who have not yet received second vaccination and in newly enrolled participants as either single dose on Day 1 or two doses on Day 1 and Day 57. Single dose of Ad26.COV2.S vaccine will also be administered to participants initially receiving placebo. Single booster dose of Ad26.COV2.S vaccine will be given to participants in the open label phase who have received only a single vaccination with Ad26.COV2.S.
Other Name: Array
Other: Placebo
Placebo will be administered as IM injection on Day 1 and Day 57.
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)
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 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
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, United States
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 Beach, 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
Saint Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Accel Research Sites
Eatonton, Georgia, United States
The University Of Chicago Medicine
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
The South Bend Clinic Center for Research
South Bend, Indiana, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Centex Studies, Inc.
Lake Charles, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
Optimal Research
Rockville, Maryland, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Cherry Street Services, Inc.
Grand Rapids, Michigan, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
Hassman Research Institute, LLC.
Berlin, New Jersey, United States
Jersey Shore University Medical Center
Neptune, New Jersey, United States
Medpharmics, LLC
Albuquerque, New Mexico, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
American Health Network, LLC
Charlotte, North Carolina, United States
Wilmington Health Associates
Wilmington, North Carolina, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Centex Studies, Inc.
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Centex Studies, Inc.
McAllen, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
Tranquility Clinical Research
Webster, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Alliance for Multispeciality Research
Norfolk, Virginia, United States
Anima
Alken, Belgium
Institute of Tropical Medicine Antwerp
Antwerpen, Belgium
Center for Vaccinology (CEVAC)
Gent, Belgium
UZ Leuven
Leuven, Belgium
Az Sint-Maarten
Mechelen, Belgium
Private Practice RESPISOM Namur
Namur, Belgium
Hospital Nossa Senhora da Conceicao S.A
Porto Alegre, Brazil
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
Rio de Janeiro, Brazil
Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ
Rio de Janeiro, Brazil
Instituto de infectologia Emilio Ribas
Sao Paulo, Brazil
Centro de Referencia E Treinamento Dst/Aids
Sao Paulo, Brazil
Fundacion Cardiomet CEQUIN
Armenia, Colombia
IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
Barranquilla, Colombia
Asistencia Cientifica de Alta Complejidad S.A.S
Bogota, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Colombia
T Y C Inversiones S A S Grupsalud
Santa Marta, Colombia
CHU de Montpellier, Hopital Saint-Eloi
Montpellier, France
Hopital Saint-Antoine
Paris Cedex 12, France
Hopital Cochin
Paris, France
Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie
Pessac, France
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne Cedex 2, France
Hopital Purpan
Toulouse Cedex 09, France
Hopital Rangueil
Toulouse, France
Hôpital de Brabois Adultes
Vandoeuvre les Nancy, France
Klinikum rechts der Isar der TU Munchen
München, Germany
Riverside Medical Center
Bacolod, Philippines
West Visayas State University Medical Center
Iloilo City, Philippines
Tropical Disease Foundation
Makati, Philippines
Makati Medical Center
Manila, Philippines
Medical Center Manila
Manila, Philippines
TREAD Research Tygerberg Hospital
Cape Town, South Africa
Centre of Tuberculosis Research Innovation
Cape Town, South Africa
Worthwhile Clinical trials
Johannesburg, South Africa
Peermed Clinical Trial Centre
Kempton Park, South Africa
Dr AA Mahomed Medical Centre
Moloto, South Africa
VX Pharma
Pretoria, South Africa
Dr J.M. Engelbrecht Trial Site
Somerset West, South Africa
Be Part Yoluntu Centre
Western Cape, South Africa
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp. Quiron Barcelona
Barcelona, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain
Hosp. Univ. Vall D Hebron
Barcelona, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Clinica Univ. de Navarra
Madrid, Spain
Hosp. Univ. de La Paz
Madrid, Spain
Hosp. Quiron Madrid Pozuelo
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Queen Elizabeth Hospital
Birmingham, United Kingdom
Powys Teaching Local Health Board - Bronllys Hospital
Brecon, United Kingdom
Brighton & Sussex University Hospitals NHS Trust
Brighton, United Kingdom
University Hospitals Bristol NHS Trust
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Royal Free Hospital
Hampstead, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Guy's and St Thomas' Hospital
London,, United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
University of Oxford
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Janssen Vaccines & Prevention B.V. Clinical Trial, Study Director
Janssen Vaccines & Prevention B.V.