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.
Biological: Ad26.COV2.S
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.
Other Name: Array
Other: Placebo
Participants will receive Placebo.
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
Synexus Clinical Research US, Inc
Birmingham, Alabama, United States
University of Alabama Birmingham
Birmingham, Alabama, United States
Alabama Vaccine Research Clinic at UAB
Birmingham, Alabama, United States
Optimal Research
Huntsville, Alabama, United States
Synexus Clinical Research US, Inc
Glendale, Arizona, United States
VA Medical Center
Phoenix, Arizona, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
Synexus Clinical Research US, Inc
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Ark Clinical Research
Long Beach, California, United States
Anthony Mills Medical, Inc
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UCSD Antiviral Research Center AVRC
San Diego, California, United States
Wr-McCr, Llc
San Diego, California, United States
VA Medical Center
San Francisco, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Rocky Mountain Regional VA Medical Center
Denver, Colorado, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
North Florida South Georgia Veteran Health System
Gainesville, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Suncoast Research Group
Miami, Florida, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Synexus Clinical Research US, Inc
Orlando, Florida, United States
Synexus Clinical Research US, Inc
Pinellas Park, Florida, United States
James A Haley VA Hospital GNS
Tampa, Florida, United States
Synexus Clinical Research US, Inc
The Villages, Florida, United States
Emory University of Medicine
Atlanta, Georgia, United States
The Hope Clinic at Emory University
Decatur, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Jesse Brown VAMC Department of Surgery
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of IL Chicago
Chicago, Illinois, United States
The University Of Chicago Medicine
Chicago, Illinois, United States
Optimal Research
Peoria, Illinois, United States
Buynak Clinical Research
Valparaiso, Indiana, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Benchmark Research
Metairie, Louisiana, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
Southeast Louisiana Veterans Health Care Center
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Baltimore VA Medical Center
Baltimore, Maryland, United States
Optimal Research
Rockville, Maryland, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, United States
University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Cherry Street Services, Inc.
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital Clinic
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
MediSync Clinical Research
Petal, Mississippi, United States
The Center For Pharmaceutical Research
Kansas City, Missouri, United States
Saint Louis University
Saint Louis, Missouri, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
Synexus Clinical Research US, Inc
Saint Louis, Missouri, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Saint Michaels Medical Center
Newark, New Jersey, United States
Raymond G. Murphy VA Medical Center
Albuquerque, New Mexico, United States
Bronx Veterans Affairs Medical Center
Bronx, New York, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Harlem Hospital Center
New York, New York, United States
New York Blood Center
New York, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Tryon Medical Group
Charlotte, North Carolina, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Durham VAMC
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Synexus Clinical Research US, Inc
Akron, Ohio, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States
Synexus Clinical Research US, Inc
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Rapid Medical Research
Cleveland, Ohio, United States
Synexus Clinical Research US, Inc
Columbus, Ohio, United States
Corvallis Clinic PC
Corvallis, Oregon, United States
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Synexus Clinical Research US, Inc
Anderson, South Carolina, United States
VA Medical Center
Columbia, South Carolina, United States
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States
PMG Research of Charleston, LLC
Mount Pleasant, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Optimal Research, LLC
Austin, Texas, United States
AIDS Arms Incorporated Trinity Health and Wellness Center
Dallas, Texas, United States
Synexus Clinical Research US, Inc
Dallas, Texas, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Gordon Crofoot, MD
Houston, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Synexus Clinical Research US, Inc
San Antonio, Texas, United States
Synexus Clinical Research US, Inc
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
CIPREC
Buenos Aires, Argentina
Helios Salud Sa
Buenos Aires, Argentina
CEMEDIC
Buenos Aires, Argentina
Centro Medico Viamonte SRL
Ciudad Autonoma Buenos Aires, Argentina
Clinical Trials Division-Stamboulian Servicios de Salud
Ciudad Autonoma Buenos Aires, Argentina
Clínica y Maternidad Suizo Argentina
Ciudad Autonoma de Buenos Aires, Argentina
Fundacion Huesped
Ciudad Autonoma De Buenos Aire, Argentina
CEMIC Saavedra
Ciudad de Buenos Aires, Argentina
Hospital J. M. Ramos Mejía
Ciudad de Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Argentina
Hospital Italiano de La Plata
La Plata, Argentina
DIM Clinica Privada
Ramos Mejia, Argentina
Faculdade de Medicina Barretos FACISB
Barretos, Brazil
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
Campinas, Brazil
Fundação Universidade Federal de Mato Grosso do Sul
Campo Grande, Brazil
Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
Criciúma, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, Brazil
Hospital Nossa Senhora Das Gracas
Curitiba, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao S.A
Porto Alegre, Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirao Preto, Brazil
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
Rio de Janeiro, Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Brazil
Fundacao Oswaldo Cruz
Rio de Janeiro, Brazil
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
Rio de Janeiro, Brazil
Fundação Bahiana De Infectologia
Salvador, Brazil
Universidade Municipal de Sao Caetano do Sul
Sao Caetano do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, Brazil
Instituto de infectologia Emilio Ribas
Sao Paulo, Brazil
Centro de Referencia E Treinamento Dst/Aids
Sao Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Sao Paulo, Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, Brazil
Centro de Estudios Clínicos e Investigación Médica (CeCim)
Santiago, Chile
Facultad de Medicina Universidad de Chile
Santiago, Chile
Hospital Padre Hurtado
Santiago, Chile
Centro de Investigacion del Maule
Talca, Chile
Hospital Dr Hernan Henriquez Aravena
Temuco, Chile
Centro de Estudios Clínicos V Región Ltda
Viña del Mar, Chile
Clinica de la Costa
Barranquilla, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, Colombia
Hospital Universidad del Norte
Barranquilla, Colombia
Centro de Atencion e Investigacion Medica S.A. - CAIMED
Bogota, Colombia
Medplus Medicina Prepagada S.A.
Bogota, Colombia
Solano y Terront Servicios Médicos Ltda.
Bogota, Colombia
Centro de Investigaciones Clinicas S.A.S.
Cali, Colombia
Fundación Valle del Lili
Cali, Colombia
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Colombia
Programa de Estudio y Control de Enfermedades Tropicales
Medellin, Colombia
Fundacion Centro de Investigacion Clinica CIC
Medellin, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Ciudad de Mexico, Mexico
Instituto Nacional de Salud Publica
Cuernavaca, Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, Mexico
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
Merida, Mexico
Centro Medico Nacional Siglo XXI IMSS
Mexico, Mexico
CAIMED Investigacion en salud S.A de C.V.
Mexico, Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico, Mexico
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
Monterrey, Mexico
Infectolab
Tijuana, Mexico
Centro de Invetigaciones Medicas
Callao, Peru
Hospital Nacional Daniel Alcides Carrion
Callao, Peru
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
Callao, Peru
Asociacion Civil Selva Amazonica (ACSA)
Iquitos, Peru
Asociacion Civil Impacta Salud y Educacion - Barranco
Lima - Barranco, Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru
Asociacion Civil Via Libre
Lima, Peru
Instituto de Investigacion Nutricional
Lima, Peru
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
Lima, Peru
Josha Research
Bloemfontein, South Africa
Synexus Helderberg Clinical Research Centre
Cape Town, South Africa
Family Clinical Research Unit FAM-CRU
Cape Town, South Africa
TASK Central
Cape Town, South Africa
Desmond Tutu HIV Foundation
Cape Town, South Africa
University of Cape Town IDM/CIDRI Research Site
Cape Town, South Africa
Desmond Tutu Hiv Foundation - University Of Cape Town
Cape Town, South Africa
Masiphumelele Research Centre
Cape Town, South Africa
Ndlovu Elandsdoorn Site
Dennilton, South Africa
SA Medical Research Council
Durban, South Africa
SA Medical Research Council
Durban, South Africa
CRISMO Bertha Gxowa Research Centre
Johannesburg, South Africa
Shandukani Research Centre
Johannesburg, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, South Africa
Qhakaza Mbokodo Research Centre
KwaZulu-Natal, South Africa
South African Medical Research Council Chatsworth Clinical Research Site
KwaZulu-Natal, South Africa
Centre for the AIDS Programme of Research in South Africa
KwaZulu-Natal, South Africa
Stanza Clinical Research Centre : Mamelodi
Mamelodi East, South Africa
Mzansi Ethical Research Centre
Middelburg, South Africa
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
Mthatha, South Africa
PHOENIX PHARMA (Pty) Ltd
Port Elizabeth, South Africa
MeCRU Clinical Research Unit
Pretoria, South Africa
Synexus Watermeyer
Pretoria, South Africa
The Aurum Institute Rustenburg Clinical Research Site
Rustenburg, South Africa
Setshaba Research Centre
Soshanguve, South Africa
Perinatal HIV Research Unit (PHRU), Kliptown
Soweto, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, South Africa
The Aurum Institute: Tembisa - Clinic 4
Tembisa, South Africa
CAPRISA Vulindlela Clinic
Vulindlela, South Africa
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
Westdene Johannesburg Gauteng, South Africa
SATVI, Brewelskloof Hospital
Worcester, South Africa
Janssen Vaccines & Prevention B.V. Clinical Trial, Study Director
Janssen Vaccines & Prevention B.V.