Back to resultsA Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)
Primary Purpose
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ad26.COV2.S
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol focused on measuring Prevention, Vaccine
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). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires
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 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 (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or 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
- Synexus Clinical Research US, Inc
- University of Alabama Birmingham
- Alabama Vaccine Research Clinic at UAB
- Optimal Research
- Synexus Clinical Research US, Inc
- VA Medical Center
- Central Phoenix Medical Clinic
- Quality of Life Medical & Research Center, LLC
- Synexus Clinical Research US, Inc
- University of Arkansas for Medical Sciences
- Central Arkansas Veterans Healthcare System
- Anaheim Clinical Trials, LLC
- Ark Clinical Research
- Anthony Mills Medical, Inc
- Stanford University Medical Center
- UCSD Antiviral Research Center AVRC
- Wr-McCr, Llc
- VA Medical Center
- Childrens Hospital Colorado
- Rocky Mountain Regional VA Medical Center
- Avail Clinical Research, LLC
- North Florida South Georgia Veteran Health System
- Velocity Clinical Research, Hallandale Beach
- Research Centers of America, LLC
- Suncoast Research Group
- University of Miami - Miller School of Medicine
- Orlando Immunology Center
- Advent Health Orlando
- Synexus Clinical Research US, Inc
- Synexus Clinical Research US, Inc
- James A Haley VA Hospital GNS
- Synexus Clinical Research US, Inc
- Emory University of Medicine
- The Hope Clinic at Emory University
- Atlanta VA Medical Center
- Northwestern University
- Jesse Brown VAMC Department of Surgery
- Rush University Medical Center
- University of IL Chicago
- The University Of Chicago Medicine
- Optimal Research
- Buynak Clinical Research
- Johnson County Clin-Trials
- Central Kentucky Research Associates, Inc.
- University of Kentucky
- University of Louisville
- Benchmark Research
- Clinical Trials Management, LLC
- New Orleans Adolescent Trials Unit CRS
- Southeast Louisiana Veterans Health Care Center
- Ochsner Clinic Foundation
- Baltimore VA Medical Center
- Optimal Research
- Meridian Clinical Research, LLC
- Massachusetts General Hospital
- The Brigham and Women's Hospital, Inc.
- University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
- Henry Ford Health System
- Cherry Street Services, Inc.
- Abbott Northwestern Hospital Clinic
- University of Mississippi Medical Center
- MediSync Clinical Research
- The Center For Pharmaceutical Research
- Saint Louis University
- Washington University School of Medicine
- Synexus Clinical Research US, Inc
- Clinical Research Center of Nevada
- Clinical Research Consortium, an AMR company
- VA Sierra Nevada Health Care System
- Rutgers Robert Wood Johnson Medical School
- Saint Michaels Medical Center
- Raymond G. Murphy VA Medical Center
- Bronx Veterans Affairs Medical Center
- Meridian Clinical Research, LLC
- Icahn School of Medicine at Mount Sinai
- Harlem Hospital Center
- New York Blood Center
- Rochester Clinical Research, Inc
- Tryon Medical Group
- Carolina Institute for Clinical Research
- Durham VAMC
- Wake Research Associates
- Wake Forest Baptist Medical Center
- Synexus Clinical Research US, Inc
- CTI Clinical Trial and Consulting Services
- Synexus Clinical Research US, Inc
- Velocity Clinical Research
- Rapid Medical Research
- Synexus Clinical Research US, Inc
- Corvallis Clinic PC
- Clinical Research Institute of Southern Oregon, P.C.
- Oregon Health & Science University
- University of Pennsylvania
- Temple University Hospital
- University of Pittsburgh
- Synexus Clinical Research US, Inc
- VA Medical Center
- Coastal Carolina Research Center
- PMG Research of Charleston, LLC
- Spartanburg Medical Research
- St Jude Children's Research Hospital
- Vanderbilt University Medical Center
- Benchmark Research
- Optimal Research, LLC
- AIDS Arms Incorporated Trinity Health and Wellness Center
- Synexus Clinical Research US, Inc
- Baylor Scott & White Research Institute
- North Texas Infectious Diseases Consultants
- The University of Texas Health Science Center at Houston
- Texas Center for Drug Development, Inc
- Gordon Crofoot, MD
- Clinical Trials of Texas, Inc
- Synexus Clinical Research US, Inc
- Synexus Clinical Research US, Inc
- University of Utah
- Advanced Clinical Research
- Kaiser Permanente Washington Health Research Institute
- CIPREC
- Helios Salud Sa
- CEMEDIC
- Centro Medico Viamonte SRL
- Clinical Trials Division-Stamboulian Servicios de Salud
- Clínica y Maternidad Suizo Argentina
- Fundacion Huesped
- CEMIC Saavedra
- Hospital J. M. Ramos Mejía
- Instituto Medico Platense
- Hospital Italiano de La Plata
- DIM Clinica Privada
- Faculdade de Medicina Barretos FACISB
- Universidade Federal De Minas Gerais - Hospital das Clínicas
- Santa Casa de Misericordia de Belo Horizonte
- L2IP - Instituto de Pesquisas Clínicas
- Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
- Fundação Universidade Federal de Mato Grosso do Sul
- Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
- Oncovida - Centro de Onco-Hematologia de Mato Grosso
- Hospital Nossa Senhora Das Gracas
- Centro de Estudos e Pesquisas em Moléstias Infecciosas
- Hospital das Clinicas de Porto Alegre
- Hospital Nossa Senhora da Conceicao S.A
- Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
- Ministerio da Saude - Hospital dos Servidores do Estado - RJ
- Instituto Brasil de Pesquisa Clinica
- Fundacao Oswaldo Cruz
- Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
- Fundação Bahiana De Infectologia
- Universidade Municipal de Sao Caetano do Sul
- Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
- Instituto de infectologia Emilio Ribas
- Centro de Referencia E Treinamento Dst/Aids
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
- CPQuali Pesquisa Clinica LTDA ME
- Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
- Real e Benemérita Associação Portuguesa de Beneficência
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
- Centro de Estudios Clínicos e Investigación Médica (CeCim)
- Facultad de Medicina Universidad de Chile
- Hospital Padre Hurtado
- Centro de Investigacion del Maule
- Hospital Dr Hernan Henriquez Aravena
- Centro de Estudios Clínicos V Región Ltda
- Clinica de la Costa
- Centro de Reumatologia y Ortopedia
- Hospital Universidad del Norte
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
- Medplus Medicina Prepagada S.A.
- Solano y Terront Servicios Médicos Ltda.
- Centro de Investigaciones Clinicas S.A.S.
- Fundación Valle del Lili
- Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
- Fundacion Oftalmologica de Santander - FOSCAL
- Programa de Estudio y Control de Enfermedades Tropicales
- Fundacion Centro de Investigacion Clinica CIC
- Hospital Pablo Tobon Uribe
- Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
- Instituto Nacional de Salud Publica
- Hospital Civil Fray Antonio Alcalde
- Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
- Centro Medico Nacional Siglo XXI IMSS
- CAIMED Investigacion en salud S.A de C.V.
- Instituto Nacional de Enfermedades Respiratorias
- Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
- Infectolab
- Centro de Invetigaciones Medicas
- Hospital Nacional Daniel Alcides Carrion
- Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
- Asociacion Civil Selva Amazonica (ACSA)
- Asociacion Civil Impacta Salud y Educacion - Barranco
- Hospital Nacional Edgardo Rebagliati Martins
- Hospital Nacional Arzobispo Loayza
- Asociacion Civil Via Libre
- Instituto de Investigacion Nutricional
- Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
- Josha Research
- Synexus Helderberg Clinical Research Centre
- Family Clinical Research Unit FAM-CRU
- TASK Central
- Desmond Tutu HIV Foundation
- University of Cape Town IDM/CIDRI Research Site
- Desmond Tutu Hiv Foundation - University Of Cape Town
- Masiphumelele Research Centre
- Ndlovu Elandsdoorn Site
- SA Medical Research Council
- SA Medical Research Council
- CRISMO Bertha Gxowa Research Centre
- Shandukani Research Centre
- The Aurum Institute Klerksdorp Clinical Research Centre
- Qhakaza Mbokodo Research Centre
- South African Medical Research Council Chatsworth Clinical Research Site
- Centre for the AIDS Programme of Research in South Africa
- Stanza Clinical Research Centre : Mamelodi
- Mzansi Ethical Research Centre
- Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
- PHOENIX PHARMA (Pty) Ltd
- MeCRU Clinical Research Unit
- Synexus Watermeyer
- The Aurum Institute Rustenburg Clinical Research Site
- Setshaba Research Centre
- Perinatal HIV Research Unit (PHRU), Kliptown
- Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
- The Aurum Institute: Tembisa - Clinic 4
- CAPRISA Vulindlela Clinic
- University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
- SATVI, Brewelskloof Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ad26.COV2.S
Placebo
Arm Description
Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Outcomes
Primary Outcome Measures
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)
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 and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute 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/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Participants who receive the booster dose was 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-booster vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
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.
Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
Number of participants with AESIs were reported. 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. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Secondary Outcome Measures
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
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 (Main Study)
The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Molecularly confirmed mild Covid-19 was 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 and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Molecularly confirmed mild Covid-19 was 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 and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Molecularly confirmed COVID-19 was 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 the study 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.
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Molecularly confirmed COVID-19 was 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 the study 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.
Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)
Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)
Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)
Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
Number of Participants With Serious Adverse Events (SAEs) (Main Study)
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.
Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)
Number of participants with AESIs were reported. 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. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)
MAAEs were 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.
Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)
MAAEs were 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 were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)
Participants who were enrolled in safety subset were 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-vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)
Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)
Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)
Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).
Full Information
NCT ID
NCT04505722
First Posted
July 31, 2020
Last Updated
May 4, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04505722
Brief Title
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Acronym
ENSEMBLE
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Keywords
Prevention, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ad26.COV2.S
Arm Type
Experimental
Arm Description
Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Intervention Type
Biological
Intervention Name(s)
Ad26.COV2.S
Other Intervention Name(s)
JNJ-78436735, Ad26COVS1
Intervention Description
Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive Placebo.
Primary Outcome Measure Information:
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)
Description
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 and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute 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/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Description
Participants who receive the booster dose was 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-booster vaccination (day of vaccination and the subsequent 7 days).
Time Frame
Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
Title
Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Description
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Time Frame
Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
Title
Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Description
Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time Frame
Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])
Title
Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
Description
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.
Time Frame
From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
Title
Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
Description
Number of participants with AESIs were reported. 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. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time Frame
From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Description
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Description
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)
Secondary Outcome Measure Information:
Title
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Description
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Description
Severe/critical COVID-19 was 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 and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
1 Day after double-blind vaccination (Day 2)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
14 days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Description
Molecularly confirmed moderate to severe/critical COVID-19 was 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. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) 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/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame
28 days after double-blind vaccination (Day 29)
Title
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Description
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.
Time Frame
14 days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Description
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
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 (Main Study)
Description
The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Description
Molecularly confirmed mild Covid-19 was 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 and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Description
Molecularly confirmed mild Covid-19 was 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 and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Description
Molecularly confirmed COVID-19 was 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 the study 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.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Description
Molecularly confirmed COVID-19 was 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 the study 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.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
Description
BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Time Frame
14 Days after double-blind vaccination (Day 15)
Title
Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
Description
BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)
Description
Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
Time Frame
From Day 29 until end of double-blind phase (up to 284 days after first vaccination)
Title
Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)
Description
Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
Time Frame
Month 6
Title
Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)
Description
Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
Time Frame
28 Days after double-blind vaccination (Day 29)
Title
Number of Participants With Serious Adverse Events (SAEs) (Main Study)
Description
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.
Time Frame
Up to 35 weeks
Title
Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)
Description
Number of participants with AESIs were reported. 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. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time Frame
Up to 35 weeks
Title
Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)
Description
MAAEs were 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.
Time Frame
Up to 6 months after double-blind vaccination on Day 1
Title
Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)
Description
MAAEs were 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 were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Time Frame
Up to 35 weeks
Title
Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)
Description
Participants who were enrolled in safety subset were 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-vaccination (day of vaccination and the subsequent 7 days).
Time Frame
Up to Day 8 (7 Days after double-blind vaccination on Day 1)
Title
Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)
Description
Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Time Frame
Up to Day 8 (7 Days after double-blind vaccination on Day 1)
Title
Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)
Description
Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time Frame
Up to Day 29 (28 Days after double-blind vaccination on Day 1)
Title
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)
Description
Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).
Time Frame
Baseline (Day 1), Day 29, and Day 71
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires
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 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 (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Synexus Clinical Research US, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alabama Vaccine Research Clinic at UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Optimal Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Anthony Mills Medical, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSD Antiviral Research Center AVRC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121-1545
Country
United States
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Regional VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
North Florida South Georgia Veteran Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Centers of America, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
James A Haley VA Hospital GNS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Emory University of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Hope Clinic at Emory University
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030-1705
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jesse Brown VAMC Department of Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of IL Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University Of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Buynak Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
New Orleans Adolescent Trials Unit CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Southeast Louisiana Veterans Health Care Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Optimal Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Brigham and Women's Hospital, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5000
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cherry Street Services, Inc.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Abbott Northwestern Hospital Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
MediSync Clinical Research
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465
Country
United States
Facility Name
The Center For Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1035
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Clinical Research Consortium, an AMR company
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Michaels Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Raymond G. Murphy VA Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Bronx Veterans Affairs Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
New York Blood Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Tryon Medical Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Durham VAMC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
CTI Clinical Trial and Consulting Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Corvallis Clinic PC
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, P.C.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-2062
Country
United States
Facility Name
VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
PMG Research of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
St Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Optimal Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
AIDS Arms Incorporated Trinity Health and Wellness Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
North Texas Infectious Diseases Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Center for Drug Development, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Gordon Crofoot, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Clinical Trials of Texas, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
CIPREC
City
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Helios Salud Sa
City
Buenos Aires
ZIP/Postal Code
C1141ACG
Country
Argentina
Facility Name
CEMEDIC
City
Buenos Aires
ZIP/Postal Code
C1440CFD
Country
Argentina
Facility Name
Centro Medico Viamonte SRL
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Clinical Trials Division-Stamboulian Servicios de Salud
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425AWK
Country
Argentina
Facility Name
Clínica y Maternidad Suizo Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1118
Country
Argentina
Facility Name
Fundacion Huesped
City
Ciudad Autonoma De Buenos Aire
ZIP/Postal Code
C1202ABB
Country
Argentina
Facility Name
CEMIC Saavedra
City
Ciudad de Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital J. M. Ramos Mejía
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1221Adc
Country
Argentina
Facility Name
Instituto Medico Platense
City
La Plata
ZIP/Postal Code
B1900AVG
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
DIM Clinica Privada
City
Ramos Mejia
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Faculdade de Medicina Barretos FACISB
City
Barretos
ZIP/Postal Code
14785-002
Country
Brazil
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
L2IP - Instituto de Pesquisas Clínicas
City
Brasília
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Fundação Universidade Federal de Mato Grosso do Sul
City
Campo Grande
ZIP/Postal Code
778606-715
Country
Brazil
Facility Name
Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
City
Criciúma
ZIP/Postal Code
88811-508
Country
Brazil
Facility Name
Oncovida - Centro de Onco-Hematologia de Mato Grosso
City
Cuiabá
ZIP/Postal Code
78043-142
Country
Brazil
Facility Name
Hospital Nossa Senhora Das Gracas
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Centro de Estudos e Pesquisas em Moléstias Infecciosas
City
Natal
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao S.A
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
City
Ribeirao Preto
ZIP/Postal Code
14040-900
Country
Brazil
Facility Name
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
City
Rio de Janeiro
ZIP/Postal Code
20221-160
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clinica
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Fundacao Oswaldo Cruz
City
Rio de Janeiro
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
City
Rio de Janeiro
ZIP/Postal Code
26030-380
Country
Brazil
Facility Name
Fundação Bahiana De Infectologia
City
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Universidade Municipal de Sao Caetano do Sul
City
Sao Caetano do Sul
ZIP/Postal Code
09521-160
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto de infectologia Emilio Ribas
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Centro de Referencia E Treinamento Dst/Aids
City
Sao Paulo
ZIP/Postal Code
02141-000
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica LTDA ME
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-901
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01323-900
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Centro de Estudios Clínicos e Investigación Médica (CeCim)
City
Santiago
ZIP/Postal Code
8331143
Country
Chile
Facility Name
Facultad de Medicina Universidad de Chile
City
Santiago
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Centro de Investigacion del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Hospital Dr Hernan Henriquez Aravena
City
Temuco
ZIP/Postal Code
47811-51
Country
Chile
Facility Name
Centro de Estudios Clínicos V Región Ltda
City
Viña del Mar
ZIP/Postal Code
2520997
Country
Chile
Facility Name
Clinica de la Costa
City
Barranquilla
ZIP/Postal Code
080001
Country
Colombia
Facility Name
Centro de Reumatologia y Ortopedia
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Hospital Universidad del Norte
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Centro de Atencion e Investigacion Medica S.A. - CAIMED
City
Bogota
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Medplus Medicina Prepagada S.A.
City
Bogota
ZIP/Postal Code
110111
Country
Colombia
Facility Name
Solano y Terront Servicios Médicos Ltda.
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Centro de Investigaciones Clinicas S.A.S.
City
Cali
ZIP/Postal Code
760001
Country
Colombia
Facility Name
Fundación Valle del Lili
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
City
Floridablanca
ZIP/Postal Code
6810002
Country
Colombia
Facility Name
Fundacion Oftalmologica de Santander - FOSCAL
City
Floridablanca
ZIP/Postal Code
681002
Country
Colombia
Facility Name
Programa de Estudio y Control de Enfermedades Tropicales
City
Medellin
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Fundacion Centro de Investigacion Clinica CIC
City
Medellin
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellín
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
City
Ciudad de Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Nacional de Salud Publica
City
Cuernavaca
ZIP/Postal Code
62100
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro Medico Nacional Siglo XXI IMSS
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
CAIMED Investigacion en salud S.A de C.V.
City
Mexico
ZIP/Postal Code
06750
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Infectolab
City
Tijuana
ZIP/Postal Code
CP 22010
Country
Mexico
Facility Name
Centro de Invetigaciones Medicas
City
Callao
ZIP/Postal Code
0000
Country
Peru
Facility Name
Hospital Nacional Daniel Alcides Carrion
City
Callao
ZIP/Postal Code
02
Country
Peru
Facility Name
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
City
Callao
ZIP/Postal Code
07066
Country
Peru
Facility Name
Asociacion Civil Selva Amazonica (ACSA)
City
Iquitos
ZIP/Postal Code
16001
Country
Peru
Facility Name
Asociacion Civil Impacta Salud y Educacion - Barranco
City
Lima - Barranco
ZIP/Postal Code
Barranco 15063
Country
Peru
Facility Name
Hospital Nacional Edgardo Rebagliati Martins
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
ZIP/Postal Code
15082
Country
Peru
Facility Name
Asociacion Civil Via Libre
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Facility Name
Instituto de Investigacion Nutricional
City
Lima
ZIP/Postal Code
LIMA12
Country
Peru
Facility Name
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
City
Lima
ZIP/Postal Code
LIMA32
Country
Peru
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Family Clinical Research Unit FAM-CRU
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
TASK Central
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation
City
Cape Town
ZIP/Postal Code
7750
Country
South Africa
Facility Name
University of Cape Town IDM/CIDRI Research Site
City
Cape Town
ZIP/Postal Code
7784
Country
South Africa
Facility Name
Desmond Tutu Hiv Foundation - University Of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Masiphumelele Research Centre
City
Cape Town
ZIP/Postal Code
7975
Country
South Africa
Facility Name
Ndlovu Elandsdoorn Site
City
Dennilton
ZIP/Postal Code
0485
Country
South Africa
Facility Name
SA Medical Research Council
City
Durban
ZIP/Postal Code
3660
Country
South Africa
Facility Name
SA Medical Research Council
City
Durban
ZIP/Postal Code
4400
Country
South Africa
Facility Name
CRISMO Bertha Gxowa Research Centre
City
Johannesburg
ZIP/Postal Code
1401
Country
South Africa
Facility Name
Shandukani Research Centre
City
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
The Aurum Institute Klerksdorp Clinical Research Centre
City
Klerksdorp
ZIP/Postal Code
2571
Country
South Africa
Facility Name
Qhakaza Mbokodo Research Centre
City
KwaZulu-Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
South African Medical Research Council Chatsworth Clinical Research Site
City
KwaZulu-Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
Centre for the AIDS Programme of Research in South Africa
City
KwaZulu-Natal
ZIP/Postal Code
4110
Country
South Africa
Facility Name
Stanza Clinical Research Centre : Mamelodi
City
Mamelodi East
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
City
Mthatha
ZIP/Postal Code
5099
Country
South Africa
Facility Name
PHOENIX PHARMA (Pty) Ltd
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
MeCRU Clinical Research Unit
City
Pretoria
ZIP/Postal Code
0204
Country
South Africa
Facility Name
Synexus Watermeyer
City
Pretoria
Country
South Africa
Facility Name
The Aurum Institute Rustenburg Clinical Research Site
City
Rustenburg
ZIP/Postal Code
300
Country
South Africa
Facility Name
Setshaba Research Centre
City
Soshanguve
ZIP/Postal Code
152
Country
South Africa
Facility Name
Perinatal HIV Research Unit (PHRU), Kliptown
City
Soweto
ZIP/Postal Code
1809
Country
South Africa
Facility Name
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
The Aurum Institute: Tembisa - Clinic 4
City
Tembisa
ZIP/Postal Code
1632
Country
South Africa
Facility Name
CAPRISA Vulindlela Clinic
City
Vulindlela
ZIP/Postal Code
4013
Country
South Africa
Facility Name
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
City
Westdene Johannesburg Gauteng
ZIP/Postal Code
2092
Country
South Africa
Facility Name
SATVI, Brewelskloof Hospital
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
35139271
Citation
Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Van Dromme I, Spiessens B, Vingerhoets J, Custers J, Scheper G, Robb ML, Treanor J, Ryser MF, Barouch DH, Swann E, Marovich MA, Neuzil KM, Corey L, Stoddard J, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. N Engl J Med. 2022 Mar 3;386(9):847-860. doi: 10.1056/NEJMoa2117608. Epub 2022 Feb 9.
Results Reference
derived
PubMed Identifier
34824596
Citation
Sadoff J, Struyf F, Douoguih M. A plain language summary of how well the single-dose Janssen vaccine works and how safe it is. Future Virol. 2021 Nov;16(11):725-739. doi: 10.2217/fvl-2021-0199. Epub 2021 Nov 1.
Results Reference
derived
PubMed Identifier
33882225
Citation
Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.
Results Reference
derived
PubMed Identifier
33524316
Citation
Williams TC, Burgers WA. SARS-CoV-2 evolution and vaccines: cause for concern? Lancet Respir Med. 2021 Apr;9(4):333-335. doi: 10.1016/S2213-2600(21)00075-8. Epub 2021 Jan 29. No abstract available.
Results Reference
derived
Learn more about this trial
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
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