A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants | NCT04505722 | Trialant

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants | NCT04505722 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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

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