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

• ClinicalTrials.gov Identifier: NCT04614948
• Recruitment Status: Active, not recruiting
• First Posted: November 4, 2020
• Last Update Posted: March 15, 2023
• Sponsor: Janssen Vaccines & Prevention B.V.
• Information provided by (Responsible Party): Janssen Vaccines & Prevention B.V.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19	Biological: Ad26.COV2.S; Other: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31831 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
• Actual Study Start Date: November 12, 2020
• Estimated Primary Completion Date: June 19, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ad26.COV2.S; 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; 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 Names: JNJ-78436735; Ad26COVS1; VAC31518
Placebo Comparator: Placebo; 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; 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 Names: JNJ-78436735; Ad26COVS1; VAC31518; Other: Placebo; Placebo will be administered as IM injection on Day 1 and Day 57.

Outcome Measures

Primary Outcome Measures :

1. Double Blind Phase and Open-label Phase: Number of Participants with Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 [ Time Frame: At least 14 days after the second vaccination (Day 71) to the end of study (2 years and 3 months [after last participant enrolled]) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance.

Secondary Outcome Measures :

1. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
2. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
3. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
4. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
5. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 28 days after the 1st vaccination (Day 29) to end of study (2 years and 3 months) ]
   Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
6. Double Blind Phase: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
   Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) and linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported.
7. Double Blind Phase: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
   The viral load of Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
8. Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
   Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive 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. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
9. Double Blind Phase: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
   Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive 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; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
10. Double Blind Phase: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
    BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case.
11. Double Blind Phase: Serologic Conversion Between Baseline and Other Blood Samples up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Between baseline and unblinding visit (up to 6 months) ]
    Serologic conversion between baseline and other blood samples up to unblinding visit using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
12. Double Blind Phase: Number of Participants With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) [ Time Frame: Up to 2 years and 3 months ]
    Number of participants with asymptomatic infection as assessed by RT-PCR will be reported.
13. Double Blind Phase: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) [ Time Frame: At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months) ]
    Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported.
14. Double Blind Phase and Open-label Phase: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years and 3 months ]
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
15. Double Blind Phase and Open-label Phase: Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 2 years and 3 months ]
    AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
16. Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after the last vaccination (Up to 34 weeks) ]
    MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
17. Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation [ Time Frame: Up to 2 years and 3 months ]
    MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
18. Double Blind Phase: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ]
    Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post each vaccination (day of each vaccination and the subsequent 7 days).
19. Double Blind Phase: Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ]
    Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
20. Double Blind Phase: Number of Participants with Unsolicited Adverse Events (AEs) During 28 Days Post-vaccination [ Time Frame: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
21. Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 2 years and 3 months ]
    SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Alabama

Achieve Clinical Research, LLC

Vestavia Hills, Alabama, United States, 35216

United States, Arizona

Hope Research Institute

Phoenix, Arizona, United States, 85018

Central Phoenix Medical Clinic

Phoenix, Arizona, United States, 85020

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States, 85712

Synexus Clinical Research US, Inc

Tucson, Arizona, United States, 85712

United States, Arkansas

Woodland International Research Group

Little Rock, Arkansas, United States, 72211

United States, California

Synexus Clinical Research US, Inc

Cerritos, California, United States, 90703

eStudySite

Chula Vista, California, United States, 91911

Ark Clinical Research

Long Beach, California, United States, 90806

Anthony Mills Medical, Inc

Los Angeles, California, United States, 90069

Benchmark Research

Sacramento, California, United States, 95684

Artemis Institute for Clinical Research

San Diego, California, United States, 92103

United States, Colorado

Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado, United States, 80033

United States, Florida

JEM Research, LLC

Atlantis, Florida, United States, 33462

Prestige Clinical Research Center, Inc.

Coral Gables, Florida, United States, 33134

Avail Clinical Research, LLC

DeLand, Florida, United States, 32720

Velocity Clinical Research, Hallandale Beach

Hallandale Beach, Florida, United States, 33009

Health Awareness inc.

Jupiter, Florida, United States, 33458

Altus Research, Inc

Lake Worth, Florida, United States, 33461

Compass Research, Melbourne

Melbourne, Florida, United States, 32940

Suncoast Research Group

Miami, Florida, United States, 33135

Behavioral Clinical Research , Inc

North Miami, Florida, United States, 33161

Clinical NeuroScience Solutions, Inc

Orlando, Florida, United States, 32806

Progressive Medical Research

Port Orange, Florida, United States, 32127

Meridien Research

Saint Petersburg, Florida, United States, 33709

Palm Beach Research Center

West Palm Beach, Florida, United States, 33409

United States, Georgia

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Accel Research Sites

Eatonton, Georgia, United States, 31204

United States, Illinois

The University Of Chicago Medicine

Chicago, Illinois, United States, 60637

Great Lakes Clinical Trials

Chicago, Illinois, United States, 60640

United States, Indiana

The South Bend Clinic Center for Research

South Bend, Indiana, United States, 46617-2808

United States, Kansas

Heartland Research Associates, LLC

Newton, Kansas, United States, 67114

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

United States, Louisiana

Centex Studies, Inc.

Lake Charles, Louisiana, United States, 70601

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maryland

Centennial Medical Group

Elkridge, Maryland, United States, 21075

Optimal Research

Rockville, Maryland, United States, 20850

Meridian Clinical Research, LLC

Rockville, Maryland, United States, 20854

United States, Michigan

Henry Ford Health Systems

Detroit, Michigan, United States, 48202

Cherry Street Services, Inc.

Grand Rapids, Michigan, United States, 49503

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110-1035

United States, New Jersey

Hassman Research Institute, LLC.

Berlin, New Jersey, United States, 08009

Jersey Shore University Medical Center

Neptune, New Jersey, United States, 07753

United States, New Mexico

Medpharmics, LLC

Albuquerque, New Mexico, United States, 87102

United States, New York

Meridian Clinical Research, LLC

Endwell, New York, United States, 13760

Regional Clinical Research, Inc.

Endwell, New York, United States, 13760

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

Rochester, New York, United States, 14618

Richmond Behavioral Associates

Staten Island, New York, United States, 10312

United States, North Carolina

American Health Network, LLC

Charlotte, North Carolina, United States, 28207

Wilmington Health Associates

Wilmington, North Carolina, United States, 28401

United States, Ohio

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States, 45212

United States, Oklahoma

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States, 73112

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Coastal Carolina Research Center

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Centennial Medical Center

Nashville, Tennessee, United States, 37203

United States, Texas

Centex Studies, Inc.

Houston, Texas, United States, 77058

Centex Studies, Inc.

Houston, Texas, United States, 77073

Texas Center for Drug Development, Inc

Houston, Texas, United States, 77081

Centex Studies, Inc.

McAllen, Texas, United States, 78504

Endeavor Clinical Trials, LLC

San Antonio, Texas, United States, 78229

Tranquility Clinical Research

Webster, Texas, United States, 77598

United States, Utah

JBR Clinical Research

Salt Lake City, Utah, United States, 84107

United States, Virginia

Alliance for Multispeciality Research

Norfolk, Virginia, United States, 23502

Belgium

Anima

Alken, Belgium, 3570

Institute of Tropical Medicine Antwerp

Antwerpen, Belgium, 2000

Center for Vaccinology (CEVAC)

Gent, Belgium, 9000

UZ Leuven

Leuven, Belgium, 3000

Az Sint-Maarten

Mechelen, Belgium, 2800

Private Practice RESPISOM Namur

Namur, Belgium, 5101

Brazil

Hospital Nossa Senhora da Conceicao S.A

Porto Alegre, Brazil, 91350-200

Ministerio da Saude - Hospital dos Servidores do Estado - RJ

Rio de Janeiro, Brazil, 20221-160

Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

Rio de Janeiro, Brazil, 21040-900

Instituto de infectologia Emilio Ribas

Sao Paulo, Brazil, 01246-900

Centro de Referencia E Treinamento Dst/Aids

Sao Paulo, Brazil, 02141-000

Colombia

Fundacion Cardiomet CEQUIN

Armenia, Colombia

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

Barranquilla, Colombia, 80020

Asistencia Cientifica de Alta Complejidad S.A.S

Bogota, Colombia

Centro Medico Imbanaco de Cali S.A.

Cali, Colombia, 760042

T Y C Inversiones S A S Grupsalud

Santa Marta, Colombia, 470001

France

CHU de Montpellier, Hopital Saint-Eloi

Montpellier, France, 34295 cedex 05

Hopital Saint-Antoine

Paris Cedex 12, France, 75571

Hopital Cochin

Paris, France, 75014

Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie

Pessac, France, 33604

CHU Saint-Etienne - Hôpital Nord

Saint-Etienne Cedex 2, France, 42055

Hopital Purpan

Toulouse Cedex 09, France, 31059

Hopital Rangueil

Toulouse, France, 31054

Hôpital de Brabois Adultes

Vandoeuvre les Nancy, France, 54511

Germany

Klinikum rechts der Isar der TU Munchen

München, Germany, 81675

Philippines

Riverside Medical Center

Bacolod, Philippines, 6100

West Visayas State University Medical Center

Iloilo City, Philippines, 5000

Tropical Disease Foundation

Makati, Philippines, 1230

Makati Medical Center

Manila, Philippines, 1000

Medical Center Manila

Manila, Philippines, 1000

South Africa

TREAD Research Tygerberg Hospital

Cape Town, South Africa, 7500

Centre of Tuberculosis Research Innovation

Cape Town, South Africa, 7700

Worthwhile Clinical trials

Johannesburg, South Africa, 1501

Peermed Clinical Trial Centre

Kempton Park, South Africa, 1619

Dr AA Mahomed Medical Centre

Moloto, South Africa, 1022

VX Pharma

Pretoria, South Africa, 0002

Dr J.M. Engelbrecht Trial Site

Somerset West, South Africa, 7130

Be Part Yoluntu Centre

Western Cape, South Africa, 7626

Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain, 08916

Hosp. Quiron Barcelona

Barcelona, Spain, 08023

Hosp. Clinic I Provincial de Barcelona

Barcelona, Spain, 08063

Hosp. Univ. Vall D Hebron

Barcelona, Spain, 8035

Hosp. Univ. de La Princesa

Madrid, Spain, 28006

Clinica Univ. De Navarra

Madrid, Spain, 28027

Hosp. Univ. de La Paz

Madrid, Spain, 28046

Hosp. Quiron Madrid Pozuelo

Madrid, Spain, 28223

Clinica Univ. De Navarra

Pamplona, Spain, 31008

United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2GW

Powys Teaching Local Health Board - Bronllys Hospital

Brecon, United Kingdom, LD3 0UL

Brighton & Sussex University Hospitals NHS Trust

Brighton, United Kingdom, BN2 5BE

University Hospitals Bristol NHS Trust

Bristol, United Kingdom, BS2 8HW

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Royal Free Hospital

Hampstead, United Kingdom, NW3 2QG

Leicester Royal Infirmary

Leicester, United Kingdom

Guy's and St Thomas' Hospital

London,, United Kingdom, SE1 9RT

Imperial College London and Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1NY

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom, M13 9WL

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE1 4LP

University of Oxford

Oxford, United Kingdom, OX3 7JX

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2SB

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Janssen Vaccines & Prevention B.V.

Investigators

• Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial; Janssen Vaccines & Prevention B.V.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Lancet Infect Dis. 2022 Nov 7;:

• Responsible Party: Janssen Vaccines & Prevention B.V.
• ClinicalTrials.gov Identifier: NCT04614948
• Other Study ID Numbers: CR108916; 2020-003643-29 ( EudraCT Number ); VAC31518COV3009 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
• First Posted: November 4, 2020
• Last Update Posted: March 15, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases