Clinical trial NCT04505722: A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Keywords: Prevention
Vaccine
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2020-08-10
Enrollment: 44325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
measure: 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
timeFrame: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
measure: Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
timeFrame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
measure: Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
timeFrame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
measure: Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
timeFrame: Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])
Secondary outcomes:
measure: 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
timeFrame: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
measure: 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
timeFrame: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
timeFrame: 1 day after double-blind vaccination on Day 1 (Day 2)
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
timeFrame: 14 days after double-blind vaccination on Day 1 (Day 15)
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
timeFrame: 28 days after double-blind vaccination on Day 1 (Day 29)
measure: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)
timeFrame: 14 days after double-blind vaccination on Day 1 (Day 15)
measure: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)
timeFrame: 28 Days after double-blind vaccination on Day 1 (Day 29)
measure: Area Under the Curve (AUC) of 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 (Double Blind Phase)
timeFrame: From Day 15 to end of the COVID-19 episode (Day 189)
measure: Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase
timeFrame: 14 Days after double-blind vaccination on Day1 (Day 15)
measure: Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase)
timeFrame: 28 Days after double-blind vaccination on Day 1 (Day 29)
measure: Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)
timeFrame: 14 Days after double-blind vaccination on Day 1 (Day 15)
measure: Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)
timeFrame: 28 Days after double-blind vaccination on Day 1 (Day 29)
measure: Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)
timeFrame: 14 Days after double-blind vaccination on Day 1 (Day 15)
measure: Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)
timeFrame: 28 Days after double-blind vaccination on Day 1 (Day 29)
measure: Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase)
timeFrame: From Day 29 until end of double-blind phase at Month 6
measure: Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase)
timeFrame: Month 6
measure: Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase)
timeFrame: 28 days after double-blind vaccination on Day 1 (Day 29)
measure: Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase)
timeFrame: 1 day after double-blind vaccination on Day 1 (Day 2)
measure: Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase)
timeFrame: Baseline (Day 1) up to 35 weeks
measure: Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase)
timeFrame: Baseline (Day 1) up to 35 weeks
measure: Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase)
timeFrame: Up to 6 months after double-blind vaccination on Day 1 (up to 6 months)
measure: Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase)
timeFrame: Up to 35 weeks
measure: Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase)
timeFrame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)
measure: Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase)
timeFrame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)
measure: Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase)
timeFrame: Up to Day 29 (28 Days after double-blind vaccination on Day 1)
measure: Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase)
timeFrame: Baseline (Day 1), Day 29, and Day 71
measure: Number of Participants With Antibody Titers to Ad26.COV2.S (Booster Phase)
timeFrame: 28 days after booster vaccination on Day 365 (up to Day 393)
measure: Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase)
timeFrame: 29 days after booster vaccination on Day 365 (Day 394)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synexus Clinical Research US Inc
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Alabama Vaccine Research Clinic at UAB
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: Glendale
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Phoenix
country: United States
facility: VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Tucson
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Angeles
country: United States
facility: Anthony Mills Medical, Inc
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center AVRC
state: California
city: San Diego
country: United States
facility: Wr McCr Llc
state: California
city: San Francisco
country: United States
facility: VA Medical Center
state: California
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: North Florida South Georgia Veteran Health System
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: University of Miami - Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Tampa
country: United States
facility: James A Haley VA Hospital GNS
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Atlanta
country: United States
facility: Emory University of Medicine
state: Georgia
city: Decatur
country: United States
facility: The Hope Clinic at Emory University
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VAMC Department of Surgery
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of IL Chicago
state: Illinois
city: Chicago
country: United States
facility: The University Of Chicago Medicine
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Valparaiso
country: United States
facility: Buynak Clinical Research
state: Indiana
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Adolescent Trials Unit CRS
state: Louisiana
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: The Brigham and Women's Hospital, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cherry Street Services, Inc.
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Petal
country: United States
facility: MediSync Clinical Research
state: Mississippi
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US Inc
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium, an AMR company
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: Saint Michaels Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Raymond G. Murphy VA Medical Center
state: New Mexico
city: Bronx
country: United States
facility: Bronx Veterans Affairs Medical Center
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: New York
country: United States
facility: New York Blood Center
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Charlotte
country: United States
facility: Tryon Medical Group
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Durham VAMC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Corvallis
country: United States
facility: Corvallis Clinic PC
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, P.C.
state: Oregon
city: Portland
country: United States
facility: Oregon Health And Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US Inc
state: South Carolina
city: Columbia
country: United States
facility: VA Medical Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Optimal Research, LLC
state: Texas
city: Dallas
country: United States
facility: AIDS Arms Incorporated Trinity Health and Wellness Center
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US Inc
state: Texas
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development Inc
state: Texas
city: Houston
country: United States
facility: Gordon Crofoot, MD
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US Inc
state: Texas
city: Murray
country: United States
facility: Synexus Clinical Research US Inc
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Buenos Aires
country: Argentina
facility: Helios Salud Sa
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Medico Viamonte SRL
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinical Trials Division-Stamboulian Servicios de Salud
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Clínica y Maternidad Suizo Argentina
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Fundacion Huesped
city: Ciudad de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital J. M. Ramos Mejía
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Ramos Mejia
country: Argentina
facility: DIM Clinica Privada
city: Barretos
country: Brazil
facility: Faculdade de Medicina Barretos FACISB
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Campo Grande
country: Brazil
facility: Fundacao Universidade Federal de Mato Grosso do Sul
city: Criciúma
country: Brazil
facility: Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
city: Cuiaba
country: Brazil
facility: Oncovida - Centro de Onco-Hematologia de Mato Grosso
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora Das Gracas
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao S A
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Rio de Janeiro
country: Brazil
facility: Ministerio da Saude - Hospital dos Servidores do Estado - RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clinica
city: Rio de Janeiro
country: Brazil
facility: Fundacao Oswaldo Cruz
city: Rio de Janeiro
country: Brazil
facility: Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
city: Salvador
country: Brazil
facility: Fundacao Bahiana De Infectologia
city: Sao Caetano do Sul
country: Brazil
facility: Universidade Municipal de Sao Caetano do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Instituto de infectologia Emilio Ribas
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: Sao Paulo
country: Brazil
facility: Centro de Referencia E Treinamento Dst/Aids
city: Sao Paulo
country: Brazil
facility: CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos e Investigación Médica (CeCim)
city: Santiago
country: Chile
facility: Facultad de Medicina Universidad de Chile
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
city: Temuco
country: Chile
facility: Hospital Dr Hernan Henriquez Aravena
city: Vina del Mar
country: Chile
facility: Centro de Estudios Clinicos V Region Ltda
city: Barranquilla
country: Colombia
facility: Clinica de la Costa
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
city: Barranquilla
country: Colombia
facility: Hospital Universidad del Norte
city: Bogota
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED
city: Bogota
country: Colombia
facility: Medplus Medicina Prepagada S.A.
city: Bogota
country: Colombia
facility: Solano y Terront Servicios Médicos Ltda.
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S A S
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL
city: Medellin
country: Colombia
facility: Programa de Estudio y Control de Enfermedades Tropicales
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC
city: Medellín
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Publica
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
city: Merida
country: Mexico
facility: Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
city: Mexico
country: Mexico
facility: Centro Medico Nacional Siglo XXI IMSS
city: Mexico
country: Mexico
facility: CAIMED Investigacion en salud S.A de C.V.
city: Mexico
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
city: Tijuana
country: Mexico
facility: Infectolab
city: Callao
country: Peru
facility: Centro de Invetigaciones Medicas
city: Callao
country: Peru
facility: Hospital Nacional Daniel Alcides Carrion
city: Callao
country: Peru
facility: Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica (ACSA)
city: Lima - Barranco
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion - Barranco
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Asociacion Civil Via Libre
city: Lima
country: Peru
facility: Instituto de Investigacion Nutricional
city: Lima
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
city: Cape Town
country: South Africa
facility: Family Clinical Research Unit FAM-CRU
city: Cape Town
country: South Africa
facility: TASK Central
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
city: Cape Town
country: South Africa
facility: University of Cape Town IDM/CIDRI Research Site
city: Cape Town
country: South Africa
facility: Desmond Tutu Hiv Foundation - University Of Cape Town
city: Cape Town
country: South Africa
facility: Masiphumelele Research Centre
city: Dennilton
country: South Africa
facility: Ndlovu Elandsdoorn Site
city: Durban
country: South Africa
facility: SA Medical Research Council
city: Durban
country: South Africa
facility: SA Medical Research Council
city: Johannesburg
country: South Africa
facility: CRISMO Bertha Gxowa Research Centre
city: Johannesburg
country: South Africa
facility: Shandukani Research Centre
city: Klerksdorp
country: South Africa
facility: The Aurum Institute Klerksdorp Clinical Research Centre
city: KwaZulu-Natal
country: South Africa
facility: Qhakaza Mbokodo Research Centre
city: KwaZulu-Natal
country: South Africa
facility: South African Medical Research Council Chatsworth Clinical Research Site
city: KwaZulu-Natal
country: South Africa
facility: Centre for the AIDS Programme of Research in South Africa
city: Mamelodi East
country: South Africa
facility: Stanza Clinical Research Centre : Mamelodi
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
city: Port Elizabeth
country: South Africa
facility: PHOENIX PHARMA (Pty) Ltd
city: Pretoria
country: South Africa
facility: MeCRU Clinical Research Unit
city: Pretoria
country: South Africa
facility: Synexus Watermeyer
city: Rustenburg
country: South Africa
facility: The Aurum Institute Rustenburg Clinical Research Site
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit (PHRU), Kliptown
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
city: Tembisa
country: South Africa
facility: The Aurum Institute: Tembisa - Clinic 4
city: Vulindlela
country: South Africa
facility: CAPRISA Vulindlela Clinic
city: Westdene Johannesburg Gauteng
country: South Africa
facility: University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
city: Worcester
country: South Africa
facility: SATVI, Brewelskloof Hospital
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.