A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
ENSEMBLE
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
2 other identifiers
interventional
44,325
8 countries
225
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Typical duration for phase_3
225 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
September 7, 2020
CompletedResults Posted
Study results publicly available
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedFebruary 4, 2025
January 1, 2025
2.6 years
July 31, 2020
January 25, 2022
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase
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.
From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind 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/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.
From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Participants who received the booster dose 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-booster vaccination (day of vaccination and the subsequent 7 days).
Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
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.
Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
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.
Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])
Secondary Outcomes (28)
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase
From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase
From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
1 day after double-blind vaccination on Day 1 (Day 2)
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
14 days after double-blind vaccination on Day 1 (Day 15)
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
28 days after double-blind vaccination on Day 1 (Day 29)
- +23 more secondary outcomes
Study Arms (2)
Ad26.COV2.S
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
- All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
- Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 \[COVID 19\] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires
You may not qualify if:
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
- Participant 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (225)
Synexus Clinical Research US Inc
Birmingham, Alabama, 35209, United States
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Alabama Vaccine Research Clinic at UAB
Birmingham, Alabama, 35294, United States
Optimal Research
Huntsville, Alabama, 35802, United States
Synexus Clinical Research US Inc
Glendale, Arizona, 85308, United States
VA Medical Center
Phoenix, Arizona, 85012, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Synexus Clinical Research US Inc
Tucson, Arizona, 85712, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Ark Clinical Research
Long Beach, California, 90806, United States
Anthony Mills Medical, Inc
Los Angeles, California, 90069, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
UCSD Antiviral Research Center AVRC
San Diego, California, 92103, United States
Wr McCr Llc
San Diego, California, 92108, United States
VA Medical Center
San Francisco, California, 94121-1545, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Rocky Mountain Regional VA Medical Center
Denver, Colorado, 80220, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
North Florida South Georgia Veteran Health System
Gainesville, Florida, 32608, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Research Centers of America, LLC
Hollywood, Florida, 33024, United States
Suncoast Research Group
Miami, Florida, 33135, United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Advent Health Orlando
Orlando, Florida, 32804, United States
Synexus Clinical Research US Inc
Orlando, Florida, 32806, United States
Synexus Clinical Research US Inc
Pinellas Park, Florida, 33781, United States
James A Haley VA Hospital GNS
Tampa, Florida, 33612, United States
Synexus Clinical Research US Inc
The Villages, Florida, 32162, United States
Emory University of Medicine
Atlanta, Georgia, 30322, United States
The Hope Clinic at Emory University
Decatur, Georgia, 30030-1705, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Northwestern University
Chicago, Illinois, 60611, United States
Jesse Brown VAMC Department of Surgery
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of IL Chicago
Chicago, Illinois, 60612, United States
The University Of Chicago Medicine
Chicago, Illinois, 60637, United States
Optimal Research
Peoria, Illinois, 61614, United States
Buynak Clinical Research
Valparaiso, Indiana, 46383, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, 70118, United States
Southeast Louisiana Veterans Health Care Center
New Orleans, Louisiana, 70119, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
Optimal Research
Rockville, Maryland, 20850, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115, United States
University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109-5000, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cherry Street Services, Inc.
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern Hospital Clinic
Minneapolis, Minnesota, 55407, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MediSync Clinical Research
Petal, Mississippi, 39465, United States
The Center For Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Saint Louis University
St Louis, Missouri, 63106, United States
Washington University School Of Medicine
St Louis, Missouri, 63110-1035, United States
Synexus Clinical Research US Inc
St Louis, Missouri, 63141, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106, United States
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, 89119, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89509, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
Raymond G. Murphy VA Medical Center
Albuquerque, New Mexico, 87108, United States
Meridian Clinical Research, LLC
Endwell, New York, 13760, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Harlem Hospital Center
New York, New York, 10037, United States
New York Blood Center
New York, New York, 10065, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Bronx Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
Tryon Medical Group
Charlotte, North Carolina, 28210, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304, United States
Durham VAMC
Raleigh, North Carolina, 27610, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Synexus Clinical Research US Inc
Akron, Ohio, 44311, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212, United States
Synexus Clinical Research US Inc
Cincinnati, Ohio, 45236, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Synexus Clinical Research US Inc
Columbus, Ohio, 43212, United States
Corvallis Clinic PC
Corvallis, Oregon, 97330, United States
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, 97504, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Synexus Clinical Research US Inc
Anderson, South Carolina, 29621-2062, United States
VA Medical Center
Columbia, South Carolina, 29201, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
St Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Benchmark Research
Austin, Texas, 78705, United States
Optimal Research, LLC
Austin, Texas, 78705, United States
AIDS Arms Incorporated Trinity Health and Wellness Center
Dallas, Texas, 75208, United States
Synexus Clinical Research US Inc
Dallas, Texas, 75234, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75246, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texas Center for Drug Development Inc
Houston, Texas, 77081, United States
Gordon Crofoot, MD
Houston, Texas, 77098, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Synexus Clinical Research US Inc
San Antonio, Texas, 78229, United States
Synexus Clinical Research US Inc
Murray, Utah, 84123, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
Clínica y Maternidad Suizo Argentina
Buenos Aires, 1118, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
Helios Salud Sa
Buenos Aires, C1141ACG, Argentina
CEMEDIC
Buenos Aires, C1440CFD, Argentina
Centro Medico Viamonte SRL
Ciudad Autonoma Buenos Aires, C1120AAC, Argentina
Clinical Trials Division-Stamboulian Servicios de Salud
Ciudad Autonoma Buenos Aires, C1425AWK, Argentina
Fundacion Huesped
Ciudad Autonoma de Buenos Aire, C1202ABB, Argentina
CEMIC Saavedra
Ciudad de Buenos Aires, 1431, Argentina
Hospital J. M. Ramos Mejía
Ciudad de Buenos Aires, C1221Adc, Argentina
Instituto Medico Platense
La Plata, B1900AVG, Argentina
Hospital Italiano de La Plata
La Plata, B1900AXI, Argentina
DIM Clinica Privada
Ramos Mejía, B1704ETD, Argentina
Faculdade de Medicina Barretos FACISB
Barretos, 14785-002, Brazil
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, 70200 730, Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904, Brazil
Fundacao Universidade Federal de Mato Grosso do Sul
Campo Grande, 778606-715, Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, 88811-508, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, 78043-142, Brazil
Hospital Nossa Senhora Das Gracas
Curitiba, 80810-040, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal, 59025-050, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, 91350 200, Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14040 900, Brazil
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
Rio de Janeiro, 20221-160, Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
Fundacao Oswaldo Cruz
Rio de Janeiro, 21040-900, Brazil
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
Rio de Janeiro, 26030-380, Brazil
Fundacao Bahiana De Infectologia
Salvador, 40110-060, Brazil
Universidade Municipal de Sao Caetano do Sul
São Caetano do Sul, 09521-160, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000, Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228-000, Brazil
Instituto de infectologia Emilio Ribas
São Paulo, 01246-900, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo, 01308 901, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900, Brazil
Centro de Referencia E Treinamento Dst/Aids
São Paulo, 02141-000, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, 04266-010, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 000, Brazil
Centro de Estudios Clínicos e Investigación Médica (CeCim)
Santiago, 8331143, Chile
Facultad de Medicina Universidad de Chile
Santiago, 8380453, Chile
Hospital Padre Hurtado
Santiago, 8880465, Chile
Centro de Investigacion del Maule
Talca, 3465586, Chile
Hospital Dr Hernan Henriquez Aravena
Temuco, 47811-51, Chile
Centro de Estudios Clinicos V Region Ltda
Viña del Mar, 2520997, Chile
Clinica de la Costa
Barranquilla, 080001, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, 080020, Colombia
Hospital Universidad del Norte
Barranquilla, 80020, Colombia
Centro de Atencion e Investigacion Medica S.A. - CAIMED
Bogotá, 00000, Colombia
Medplus Medicina Prepagada S.A.
Bogotá, 110111, Colombia
Solano y Terront Servicios Médicos Ltda.
Bogotá, 110221, Colombia
Centro de Investigaciones Clinicas S A S
Cali, 760001, Colombia
Fundación Valle del Lili
Cali, 760032, Colombia
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, 6810002, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, 681002, Colombia
Programa de Estudio y Control de Enfermedades Tropicales
Medellín, 00000, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Fundacion Centro de Investigacion Clinica CIC
Medellín, Colombia
Instituto Nacional de Salud Publica
Cuernavaca, 62100, Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
Mérida, 97000, Mexico
Centro Medico Nacional Siglo XXI IMSS
México, 06720, Mexico
CAIMED Investigacion en salud S.A de C.V.
México, 06750, Mexico
Instituto Nacional de Enfermedades Respiratorias
México, 14080, Mexico
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
Monterrey, 64460, Mexico
Infectolab
Tijuana, CP 22010, Mexico
Centro de Invetigaciones Medicas
Callao, 0000, Peru
Hospital Nacional Daniel Alcides Carrion
Callao, 02, Peru
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
Callao, 07066, Peru
Asociacion Civil Selva Amazonica (ACSA)
Iquitos, 16001, Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11, Peru
Hospital Nacional Arzobispo Loayza
Lima, 15082, Peru
Asociacion Civil Via Libre
Lima, LIMA 01, Peru
Instituto de Investigacion Nutricional
Lima, LIMA12, Peru
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
Lima, LIMA32, Peru
Asociacion Civil Impacta Salud y Educacion - Barranco
Lima - Barranco, Barranco 15063, Peru
Josha Research
Bloemfontein, 9301, South Africa
Synexus Helderberg Clinical Research Centre
Cape Town, 7130, South Africa
Family Clinical Research Unit FAM-CRU
Cape Town, 7505, South Africa
TASK Central
Cape Town, 7530, South Africa
Desmond Tutu HIV Foundation
Cape Town, 7750, South Africa
University of Cape Town IDM/CIDRI Research Site
Cape Town, 7784, South Africa
Desmond Tutu Hiv Foundation - University Of Cape Town
Cape Town, 7925, South Africa
Masiphumelele Research Centre
Cape Town, 7975, South Africa
Ndlovu Elandsdoorn Site
Dennilton, 0485, South Africa
SA Medical Research Council
Durban, 3660, South Africa
SA Medical Research Council
Durban, 4400, South Africa
CRISMO Bertha Gxowa Research Centre
Johannesburg, 1401, South Africa
Shandukani Research Centre
Johannesburg, 2001, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, 2571, South Africa
Qhakaza Mbokodo Research Centre
KwaZulu-Natal, 4030, South Africa
South African Medical Research Council Chatsworth Clinical Research Site
KwaZulu-Natal, 4030, South Africa
Centre for the AIDS Programme of Research in South Africa
KwaZulu-Natal, 4110, South Africa
Stanza Clinical Research Centre : Mamelodi
Mamelodi East, 0122, South Africa
Mzansi Ethical Research Centre
Middelburg, 1055, South Africa
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
Mthatha, 5099, South Africa
PHOENIX PHARMA (Pty) Ltd
Port Elizabeth, 6001, South Africa
MeCRU Clinical Research Unit
Pretoria, 0204, South Africa
Synexus Watermeyer
Pretoria, South Africa
The Aurum Institute Rustenburg Clinical Research Site
Rustenburg, 300, South Africa
Setshaba Research Centre
Soshanguve, 152, South Africa
Perinatal HIV Research Unit (PHRU), Kliptown
Soweto, 1809, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, 2013, South Africa
The Aurum Institute: Tembisa - Clinic 4
Tembisa, 1632, South Africa
CAPRISA Vulindlela Clinic
Vulindlela, 4013, South Africa
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
Westdene Johannesburg Gauteng, 2092, South Africa
SATVI, Brewelskloof Hospital
Worcester, 6850, South Africa
Related Publications (8)
Carpp LN, Hyrien O, Fong Y, Benkeser D, Roels S, Stieh DJ, Van Dromme I, Van Roey GA, Kenny A, Huang Y, Carone M, McDermott AB, Houchens CR, Martins K, Jayashankar L, Castellino F, Amoa-Awua O, Basappa M, Flach B, Lin BC, Moore C, Naisan M, Naqvi M, Narpala S, O'Connell S, Mueller A, Serebryannyy L, Castro M, Wang J, Petropoulos CJ, Luedtke A, Lu Y, Yu C, Juraska M, Hejazi NS, Wolfe DN, Sadoff J, Gray GE, Grinsztejn B, Goepfert PA, Bekker LG, Gaur AH, Veloso VG, Randhawa AK, Andrasik MP, Hendriks J, Truyers C, Vandebosch A, Struyf F, Schuitemaker H, Douoguih M, Kublin JG, Corey L, Neuzil KM, Follmann D, Koup RA, Donis RO, Gilbert PB; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team; United States Government (USG)/CoVPN Biostatistics Team. Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial. Nat Commun. 2024 Nov 12;15(1):9785. doi: 10.1038/s41467-024-53727-y.
PMID: 39532861DERIVEDJanes H, Fisher LH, Kee JJ, Parameswaran L, Goepfert PA, Falsey AR, Ludwig J, Magaret CA, Gilbert PB, Kublin JG, Rouphael N, Sobieszczyk ME, El Sahly HM, Baden LR, Grinsztejn B, Walsh SR, Gray GE, Kotloff KL, Gay CL, Greninger AL, Tapia MD, Hammershaimb EA, Priddy FH, Green JA, Struyf F, Dunkle L, Neuzil KM, Corey L, Huang Y. Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials. J Infect Dis. 2024 Dec 16;230(6):1384-1389. doi: 10.1093/infdis/jiae400.
PMID: 39225478DERIVEDTurley CB, Tables L, Fuller T, Sanders LJ, Scott H, Moodley A, Woodward Davis A, Leav B, Miller J, Schoemaker K, Vandebosch A, Sadoff J, Woo W, Cho I, Dunkle LM, Li S, van der Laan L, Gilbert PB, Follmann D, Jaynes H, Kublin JG, Baden LR, Goepfert P, Kotloff K, Gay CL, Falsey AR, El Sahly HM, Sobieszczyk ME, Huang Y, Neuzil KM, Corey L, Grinsztejn B, Gray G, Rouphael N, Luedtke A; COVID-19 Prevention Network CoVPN. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials. Vaccine. 2023 Jul 25;41(33):4899-4906. doi: 10.1016/j.vaccine.2023.06.066. Epub 2023 Jun 23.
PMID: 37385888DERIVEDFong Y, McDermott AB, Benkeser D, Roels S, Stieh DJ, Vandebosch A, Le Gars M, Van Roey GA, Houchens CR, Martins K, Jayashankar L, Castellino F, Amoa-Awua O, Basappa M, Flach B, Lin BC, Moore C, Naisan M, Naqvi M, Narpala S, O'Connell S, Mueller A, Serebryannyy L, Castro M, Wang J, Petropoulos CJ, Luedtke A, Hyrien O, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Wolfe DN, Sadoff J, Gray GE, Grinsztejn B, Goepfert PA, Little SJ, Paiva de Sousa L, Maboa R, Randhawa AK, Andrasik MP, Hendriks J, Truyers C, Struyf F, Schuitemaker H, Douoguih M, Kublin JG, Corey L, Neuzil KM, Carpp LN, Follmann D, Gilbert PB, Koup RA, Donis RO; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team; and the United States Government (USG)/CoVPN Biostatistics Team. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial. Nat Microbiol. 2022 Dec;7(12):1996-2010. doi: 10.1038/s41564-022-01262-1. Epub 2022 Nov 10.
PMID: 36357712DERIVEDSadoff 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.
PMID: 35139271DERIVEDSadoff 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.
PMID: 34824596DERIVEDSadoff 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.
PMID: 33882225DERIVEDWilliams 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.
PMID: 33524316DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Safety results are reported in AE section, hence not repeated again in OM section. As pre-specified in statistical analysis plan, data of efficacy OMs for OL booster phase was not collected and analyzed. As clinical development program has moved from "Development" to "Life cycle management" phase, scope and extent of open label analysis was reduced. Hence, data was not collected and analyzed for OMs of platelet count, Biomarkers With SARS-CoV-2 Infection \& COVID-19 Severity Using RNA Sequencing.
Results Point of Contact
- Title
- SENIOR ADVISOR CLINICAL DEVELOPMENT
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 10, 2020
Study Start
September 7, 2020
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
February 4, 2025
Results First Posted
April 15, 2022
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
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