A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19
About this trial
This is an interventional prevention trial for Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19
Eligibility Criteria
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
Sites / Locations
- Achieve Clinical Research, LLC
- Hope Research Institute
- Central Phoenix Medical Clinic
- Quality of Life Medical & Research Center, LLC
- Synexus Clinical Research US, Inc
- Woodland International Research Group
- Synexus Clinical Research US, Inc
- eStudySite
- Ark Clinical Research
- Anthony Mills Medical, Inc
- Benchmark Research
- Artemis Institute for Clinical Research
- Paradigm Clinical Research Centers, Inc.
- JEM Research, LLC
- Prestige Clinical Research Center, Inc.
- Avail Clinical Research, LLC
- Velocity Clinical Research, Hallandale Beach
- Health Awareness inc.
- Altus Research, Inc
- Compass Research, Melbourne
- Suncoast Research Group
- Behavioral Clinical Research , Inc
- Clinical NeuroScience Solutions, Inc
- Progressive Medical Research
- Meridien Research
- Palm Beach Research Center
- Atlanta Center for Medical Research
- Accel Research Sites
- The University Of Chicago Medicine
- Great Lakes Clinical Trials
- The South Bend Clinic Center for Research
- Heartland Research Associates, LLC
- University of Kentucky
- Centex Studies, Inc.
- Ochsner Clinic Foundation
- Centennial Medical Group
- Optimal Research
- Meridian Clinical Research, LLC
- Henry Ford Health Systems
- Cherry Street Services, Inc.
- Washington University School of Medicine
- Hassman Research Institute, LLC.
- Jersey Shore University Medical Center
- Medpharmics, LLC
- Meridian Clinical Research, LLC
- Regional Clinical Research, Inc.
- Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center
- Richmond Behavioral Associates
- American Health Network, LLC
- Wilmington Health Associates
- CTI Clinical Trial and Consulting Services
- Lynn Health Science Institute
- Medical University of South Carolina
- Coastal Carolina Research Center
- Centennial Medical Center
- Centex Studies, Inc.
- Centex Studies, Inc.
- Texas Center for Drug Development, Inc
- Centex Studies, Inc.
- Endeavor Clinical Trials, LLC
- Tranquility Clinical Research
- JBR Clinical Research
- Alliance for Multispeciality Research
- Anima
- Institute of Tropical Medicine Antwerp
- Center for Vaccinology (CEVAC)
- UZ Leuven
- Az Sint-Maarten
- Private Practice RESPISOM Namur
- Hospital Nossa Senhora da Conceicao S.A
- Ministerio da Saude - Hospital dos Servidores do Estado - RJ
- Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ
- Instituto de infectologia Emilio Ribas
- Centro de Referencia E Treinamento Dst/Aids
- Fundacion Cardiomet CEQUIN
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
- Asistencia Cientifica de Alta Complejidad S.A.S
- Centro Medico Imbanaco de Cali S.A.
- T Y C Inversiones S A S Grupsalud
- CHU de Montpellier, Hopital Saint-Eloi
- Hopital Saint-Antoine
- Hopital Cochin
- Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie
- CHU Saint-Etienne - Hôpital Nord
- Hopital Purpan
- Hopital Rangueil
- Hôpital de Brabois Adultes
- Klinikum rechts der Isar der TU Munchen
- Riverside Medical Center
- West Visayas State University Medical Center
- Tropical Disease Foundation
- Makati Medical Center
- Medical Center Manila
- TREAD Research Tygerberg Hospital
- Centre of Tuberculosis Research Innovation
- Worthwhile Clinical trials
- Peermed Clinical Trial Centre
- Dr AA Mahomed Medical Centre
- VX Pharma
- Dr J.M. Engelbrecht Trial Site
- Be Part Yoluntu Centre
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Quiron Barcelona
- Hosp. Clinic I Provincial de Barcelona
- Hosp. Univ. Vall D Hebron
- Hosp. Univ. de La Princesa
- Clinica Univ. de Navarra
- Hosp. Univ. de La Paz
- Hosp. Quiron Madrid Pozuelo
- Clinica Univ. de Navarra
- Queen Elizabeth Hospital
- Powys Teaching Local Health Board - Bronllys Hospital
- Brighton & Sussex University Hospitals NHS Trust
- University Hospitals Bristol NHS Trust
- Cambridge University Hospitals NHS Foundation Trust
- Ninewells Hospital
- Royal Free Hospital
- Leicester Royal Infirmary
- Guy's and St Thomas' Hospital
- Imperial College London and Imperial College Healthcare NHS Trust
- Central Manchester University Hospitals NHS Foundation Trust
- Newcastle upon Tyne Hospitals NHS Foundation Trust
- University of Oxford
- Derriford Hospital
- Sheffield Teaching Hospitals NHS Foundation Trust
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ad26.COV2.S
Placebo
Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants who have not yet received second vaccination will receive second dose of Ad26.COV2.S vaccine on Day 57, if applicable and newly enrolled participants will either receive IM injection of one dose of Ad26.COV2.S vaccine on Day 1 or two doses of Ad26.COV2.S vaccine on Day 1 and Day 57. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.
Participants will receive IM injection of placebo on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants initially receiving placebo will be offered to receive IM injection of a single dose of Ad26.COV2.S vaccine. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.