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

NCT04614948 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1089162020-003643-29VAC31518COV3009
• Study Type: interventional
• Target: 31,835
• Locations: 10 countries
• Sites: 126

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 14 Days After the Second Vaccination

  Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>=20 breaths per minute (min) and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>=90 beats/min and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/min, heart rate \>=125 beats/min, oxygen saturation (SpO2) \<=93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to Intensive Care Unit (ICU), death defined as per FDA guidance.

  From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Secondary Outcomes (21)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination

  From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination

  From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 1 Day After the First Day 1 Vaccination

  From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 14 Days After the First Day 1 Vaccination

  From at least 14 days after first vaccination on Day 1 (Day 15) up to end of double blind phase (7.2 months)

• Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination

  From at least 28 days after the first vaccination on Day 1 (Day 29) up to end of double blind phase (7.2 months)

Study Arms (2)

Ad26.COV2.S

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Placebo

PLACEBO COMPARATOR

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.

Biological: Ad26.COV2.S; Other: Placebo

Interventions

Ad26.COV2.S BIOLOGICAL

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.

Also known as: JNJ-78436735, Ad26COVS1, VAC31518

Ad26.COV2.S; Placebo

Placebo OTHER

Placebo will be administered as IM injection on Day 1 and Day 57.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (126)

Achieve Clinical Research, LLC

Vestavia Hills, Alabama, 35216, United States

Location

Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States

Location

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, 85712, United States

Location

Synexus Clinical Research US Inc

Tucson, Arizona, 85712, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Synexus Clinical Research US Inc

Cerritos, California, 90703, United States

Location

eStudySite

Chula Vista, California, 91911, United States

Location

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Anthony Mills Medical, Inc

Los Angeles, California, 90069, United States

Location

Benchmark Research

Sacramento, California, 95684, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

JEM Research LLC

Atlantis, Florida, 33462, United States

Location

Prestige Clinical Research Center, Inc.

Coral Gables, Florida, 33134, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Health Awareness inc.

Jupiter, Florida, 33458, United States

Location

Altus Research, Inc

Lake Worth, Florida, 33461, United States

Location

Compass Research, Melbourne

Melbourne, Florida, 32940, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Behavioral Clinical Research , Inc

North Miami, Florida, 33161, United States

Location

Clinical NeuroScience Solutions Inc

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Accel Research Sites

Eatonton, Georgia, 31204, United States

Location

The University Of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

The South Bend Clinic Center for Research

South Bend, Indiana, 46617-2808, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Centex Studies, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

Meridian Clinical Research, LLC

Rockville, Maryland, 20854, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Cherry Street Services, Inc.

Grand Rapids, Michigan, 49503, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110-1035, United States

Location

Hassman Research Institute, LLC.

Berlin, New Jersey, 08009, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Medpharmics, LLC

Albuquerque, New Mexico, 87102, United States

Location

Meridian Clinical Research, LLC

Endwell, New York, 13760, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center

Rochester, New York, 14618, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

American Health Network, LLC

Charlotte, North Carolina, 28207, United States

Location

Wilmington Health Associates

Wilmington, North Carolina, 28401, United States

Location

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, 45212, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Centex Studies, Inc.

Houston, Texas, 77073, United States

Location

Texas Center for Drug Development Inc

Houston, Texas, 77081, United States

Location

Centex Studies, Inc.

McAllen, Texas, 78504, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

Tranquility Clinical Research

Webster, Texas, 77598, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Alliance for Multispeciality Research

Norfolk, Virginia, 23502, United States

Location

Anima

Alken, 3570, Belgium

Location

Institute of Tropical Medicine Antwerp

Antwerp, 2000, Belgium

Location

Center for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Az Sint-Maarten

Mechelen, 2800, Belgium

Location

Private Practice RESPISOM Namur

Namur, 5101, Belgium

Location

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, 91350 200, Brazil

Location

Ministerio da Saude - Hospital dos Servidores do Estado - RJ

Rio de Janeiro, 20221-160, Brazil

Location

Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

Rio de Janeiro, 21040-900, Brazil

Location

Instituto de infectologia Emilio Ribas

São Paulo, 01246-900, Brazil

Location

Centro de Referencia E Treinamento Dst/Aids

São Paulo, 02141-000, Brazil

Location

Fundacion Cardiomet CEQUIN

Armenia, Colombia

Location

IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.

Barranquilla, 80020, Colombia

Location

Asistencia Cientifica de Alta Complejidad S.A.S

Bogotá, Colombia

Location

Centro Medico Imbanaco de Cali S.A.

Cali, 760042, Colombia

Location

T Y C Inversiones S A S Grupsalud

Santa Marta, 470001, Colombia

Location

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295 cedex 05, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Saint-Antoine

Paris, 75571, France

Location

Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie

Pessac, 33604, France

Location

CHU Saint Etienne Hopital Nord

Saint-Etienne, 42055, France

Location

Hopital Rangueil

Toulouse, 31054, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Klinikum rechts der Isar der TU Munchen

München, 81675, Germany

Location

Riverside Medical Center

Bacolod, 6100, Philippines

Location

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

Location

Tropical Disease Foundation

Makati, 1230, Philippines

Location

Makati Medical Center

Manila, 1000, Philippines

Location

Medical Center Manila

Manila, 1000, Philippines

Location

TREAD Research Tygerberg Hospital

Cape Town, 7500, South Africa

Location

Centre of Tuberculosis Research Innovation

Cape Town, 7700, South Africa

Location

Worthwhile Clinical trials

Johannesburg, 1501, South Africa

Location

Peermed Clinical Trial Centre

Kempton Park, 1619, South Africa

Location

Dr AA Mahomed Medical Centre

Moloto South, 1022, South Africa

Location

VX Pharma

Pretoria, 0002, South Africa

Location

Dr J.M. Engelbrecht Trial Site

Somerset West, 7130, South Africa

Location

Be Part Yoluntu Centre

Western Cape, 7626, South Africa

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Quiron Barcelona

Barcelona, 08023, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08063, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Clinica Univ. de Navarra

Madrid, 28027, Spain

Location

Hosp. Univ. de La Paz

Madrid, 28046, Spain

Location

Hosp. Quiron Madrid Pozuelo

Madrid, 28223, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Powys Teaching Local Health Board - Bronllys Hospital

Brecon, LD3 0UL, United Kingdom

Location

Brighton & Sussex University Hospitals NHS Trust

Brighton, BN2 5BE, United Kingdom

Location

University Hospitals Bristol NHS Trust

Bristol, BS2 8HW, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Royal Free Hospital

Hampstead, NW3 2QG, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

Guy's and St Thomas' Hospital

London, SE1 9RT, United Kingdom

Location

Imperial College London and Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

University of Oxford

Oxford, OX3 7JX, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SB, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Hardt K, Vandebosch A, Sadoff J, Le Gars M, Truyers C, Lowson D, Van Dromme I, Vingerhoets J, Kamphuis T, Scheper G, Ruiz-Guinazu J, Faust SN, Spinner CD, Schuitemaker H, Van Hoof J, Douoguih M, Struyf F; ENSEMBLE2 study group. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Dec;22(12):1703-1715. doi: 10.1016/S1473-3099(22)00506-0. Epub 2022 Sep 13.

  PMID: 36113538 DERIVED

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Per change in planned analysis, safety results for Open-label (OL) phase were included in the All Participants arm in AE section, hence are not repeated in OM section. There was no planned cross-over, the various complex vaccination sequences were a result of ethically allowing placebo participants to unblind themselves and receive active vaccination in OL phase. Hence data could not be analyzed separately for OL phase and was combined with DB phase after unblinding in 'All Participants' arm.

Results Point of Contact

• Title: VICE PRESIDENT Medical Affairs IDV
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 4, 2020
• Study Start: November 12, 2020
• Primary Completion: June 18, 2023
• Study Completion: June 18, 2023
• Last Updated: February 4, 2025
• Results First Posted: October 9, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (16); US (63); CO (5); BE (6); ZA (8); BR (5); PH (5); DE (1); ES (9); FR (8)