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

PHASE3CompletedINTERVENTIONAL
Enrollment

44,325

Participants

Timeline

Start Date

September 7, 2020

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2023

Conditions
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Interventions
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

Placebo

Participants will receive Placebo.

Trial Locations (225)

11

Hospital Nacional Edgardo Rebagliati Martins, Lima

152

Setshaba Research Centre, Soshanguve

300

The Aurum Institute Rustenburg Clinical Research Site, Rustenburg

1055

Mzansi Ethical Research Centre, Middelburg

1118

Clínica y Maternidad Suizo Argentina, Buenos Aires

1401

CRISMO Bertha Gxowa Research Centre, Johannesburg

1431

CEMIC Saavedra, Ciudad de Buenos Aires

1632

The Aurum Institute: Tembisa - Clinic 4, Tembisa

1809

Perinatal HIV Research Unit (PHRU), Kliptown, Soweto

2001

Shandukani Research Centre, Johannesburg

2013

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto

2092

University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre, Westdene Johannesburg Gauteng

2571

The Aurum Institute Klerksdorp Clinical Research Centre, Klerksdorp

3660

SA Medical Research Council, Durban

4013

CAPRISA Vulindlela Clinic, Vulindlela

4030

Qhakaza Mbokodo Research Centre, KwaZulu-Natal

South African Medical Research Council Chatsworth Clinical Research Site, KwaZulu-Natal

4110

Centre for the AIDS Programme of Research in South Africa, KwaZulu-Natal

4400

SA Medical Research Council, Durban

5099

Nelson Mandela Academic Clinical Research Unit 'NeMACRU', Mthatha

6001

PHOENIX PHARMA (Pty) Ltd, Port Elizabeth

6850

SATVI, Brewelskloof Hospital, Worcester

7130

Synexus Helderberg Clinical Research Centre, Cape Town

7505

Family Clinical Research Unit FAM-CRU, Cape Town

7530

TASK Central, Cape Town

7750

Desmond Tutu HIV Foundation, Cape Town

7784

University of Cape Town IDM/CIDRI Research Site, Cape Town

7925

Desmond Tutu Hiv Foundation - University Of Cape Town, Cape Town

7975

Masiphumelele Research Centre, Cape Town

9301

Josha Research, Bloemfontein

10029

Icahn School of Medicine at Mount Sinai, New York

10037

Harlem Hospital Center, New York

10065

New York Blood Center, New York

10468

Bronx Veterans Affairs Medical Center, The Bronx

13760

Meridian Clinical Research, LLC, Endwell

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

Instituto Nacional de Enfermedades Respiratorias, México

14609

Rochester Clinical Research, Inc, Rochester

15082

Hospital Nacional Arzobispo Loayza, Lima

15232

University of Pittsburgh, Pittsburgh

16001

Asociacion Civil Selva Amazonica (ACSA), Iquitos

19104

University of Pennsylvania, Philadelphia

19140

Temple University Hospital, Philadelphia

20850

Optimal Research, Rockville

20854

Meridian Clinical Research, LLC, Rockville

21201

Baltimore VA Medical Center, Baltimore

27157

Wake Forest Baptist Medical Center, Winston-Salem

27610

Durham VAMC, Raleigh

27612

Wake Research Associates, Raleigh

28210

Tryon Medical Group, Charlotte

28304

Carolina Institute for Clinical Research, Fayetteville

29201

VA Medical Center, Columbia

29303

Spartanburg Medical Research, Spartanburg

29464

Coastal Carolina Research Center, Mt. Pleasant

PMG Research of Charleston, LLC, Mt. Pleasant

30033

Atlanta VA Medical Center, Decatur

30322

Emory University of Medicine, Atlanta

32162

Synexus Clinical Research US Inc, The Villages

32608

North Florida South Georgia Veteran Health System, Gainesville

32720

Avail Clinical Research, LLC, DeLand

32803

Orlando Immunology Center, Orlando

32804

Advent Health Orlando, Orlando

32806

Synexus Clinical Research US Inc, Orlando

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33024

Research Centers of America, LLC, Hollywood

33135

Suncoast Research Group, Miami

33136

University of Miami - Miller School of Medicine, Miami

33612

James A Haley VA Hospital GNS, Tampa

33781

Synexus Clinical Research US Inc, Pinellas Park

35209

Synexus Clinical Research US Inc, Birmingham

35233

University of Alabama Birmingham, Birmingham

35294

Alabama Vaccine Research Clinic at UAB, Birmingham

35802

Optimal Research, Huntsville

37232

Vanderbilt University Medical Center, Nashville

38105

St Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

39465

MediSync Clinical Research, Petal

40202

University of Louisville, Louisville

40509

Central Kentucky Research Associates, Inc., Lexington

40536

University of Kentucky, Lexington

43212

Synexus Clinical Research US Inc, Columbus

44122

Rapid Medical Research, Cleveland

44280

Hospital Civil Fray Antonio Alcalde, Guadalajara

44311

Synexus Clinical Research US Inc, Akron

45212

CTI Clinical Trial and Consulting Services, Cincinnati

45236

Synexus Clinical Research US Inc, Cincinnati

45242

Velocity Clinical Research, Cincinnati

46383

Buynak Clinical Research, Valparaiso

48202

Henry Ford Health System, Detroit

49503

Cherry Street Services, Inc., Grand Rapids

55407

Abbott Northwestern Hospital Clinic, Minneapolis

60611

Northwestern University, Chicago

60612

Jesse Brown VAMC Department of Surgery, Chicago

Rush University Medical Center, Chicago

University of IL Chicago, Chicago

60637

The University Of Chicago Medicine, Chicago

61614

Optimal Research, Peoria

62100

Instituto Nacional de Salud Publica, Cuernavaca

63106

Saint Louis University, St Louis

63141

Synexus Clinical Research US Inc, St Louis

64114

The Center For Pharmaceutical Research, Kansas City

64460

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez', Monterrey

66219

Johnson County Clin-Trials, Lenexa

70006

Benchmark Research, Metairie

Clinical Trials Management, LLC, Metairie

70118

New Orleans Adolescent Trials Unit CRS, New Orleans

70119

Southeast Louisiana Veterans Health Care Center, New Orleans

70121

Ochsner Clinic Foundation, New Orleans

72202

University of Arkansas for Medical Sciences, Little Rock

72205

Central Arkansas Veterans Healthcare System, Little Rock

75208

AIDS Arms Incorporated Trinity Health and Wellness Center, Dallas

75234

Synexus Clinical Research US Inc, Dallas

75246

Baylor Scott and White Research Institute, Dallas

North Texas Infectious Diseases Consultants, Dallas

77030

The University of Texas Health Science Center at Houston, Houston

77081

Texas Center for Drug Development Inc, Houston

77098

Gordon Crofoot, MD, Houston

78229

Clinical Trials of Texas Inc, San Antonio

Synexus Clinical Research US Inc, San Antonio

78705

Benchmark Research, Austin

Optimal Research, LLC, Austin

80020

Hospital Universidad del Norte, Barranquilla

80045

Childrens Hospital Colorado, Aurora

80220

Rocky Mountain Regional VA Medical Center, Denver

84088

Advanced Clinical Research, West Jordan

84123

Synexus Clinical Research US Inc, Murray

84132

University of Utah, Salt Lake City

85012

VA Medical Center, Phoenix

85020

Central Phoenix Medical Clinic, Phoenix

85308

Synexus Clinical Research US Inc, Glendale

85712

Quality of Life Medical & Research Center, LLC, Tucson

Synexus Clinical Research US Inc, Tucson

87108

Raymond G. Murphy VA Medical Center, Albuquerque

89106

Clinical Research Center of Nevada, Las Vegas

89119

Clinical Research Consortium, an AMR company, Las Vegas

89509

VA Sierra Nevada Health Care System, Reno

90069

Anthony Mills Medical, Inc, Los Angeles

90806

Ark Clinical Research, Long Beach

92103

UCSD Antiviral Research Center AVRC, San Diego

92108

Wr McCr Llc, San Diego

92801

Anaheim Clinical Trials, LLC, Anaheim

94304

Stanford University Medical Center, Palo Alto

97000

Unidad de Atención Medica e Investigacion en Salud (UNAMIS), Mérida

97239

Oregon Health And Science University, Portland

97330

Corvallis Clinic PC, Corvallis

97504

Clinical Research Institute of Southern Oregon, P.C., Medford

98101

Kaiser Permanente Washington Health Research Institute, Seattle

110111

Medplus Medicina Prepagada S.A., Bogotá

110221

Solano y Terront Servicios Médicos Ltda., Bogotá

681002

Fundacion Oftalmologica de Santander - FOSCAL, Floridablanca

760001

Centro de Investigaciones Clinicas S A S, Santiago de Cali

760032

Fundación Valle del Lili, Santiago de Cali

2520997

Centro de Estudios Clinicos V Region Ltda, Viña del Mar

3465586

Centro de Investigacion del Maule, Talca

6810002

Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca, Floridablanca

8331143

Centro de Estudios Clínicos e Investigación Médica (CeCim), Santiago

8380453

Facultad de Medicina Universidad de Chile, Santiago

8880465

Hospital Padre Hurtado, Santiago

94121-1545

VA Medical Center, San Francisco

30030-1705

The Hope Clinic at Emory University, Decatur

02114

Massachusetts General Hospital, Boston

02115

The Brigham and Women's Hospital, Inc., Boston

48109-5000

University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center, Ann Arbor

63110-1035

Washington University School Of Medicine, St Louis

08903

Rutgers Robert Wood Johnson Medical School, New Brunswick

07102

Saint Michaels Medical Center, Newark

29621-2062

Synexus Clinical Research US Inc, Anderson

C1119ACN

CIPREC, Buenos Aires

C1141ACG

Helios Salud Sa, Buenos Aires

C1440CFD

CEMEDIC, Buenos Aires

C1120AAC

Centro Medico Viamonte SRL, Ciudad Autonoma Buenos Aires

C1425AWK

Clinical Trials Division-Stamboulian Servicios de Salud, Ciudad Autonoma Buenos Aires

C1202ABB

Fundacion Huesped, Ciudad Autonoma de Buenos Aire

C1221Adc

Hospital J. M. Ramos Mejía, Ciudad de Buenos Aires

B1900AVG

Instituto Medico Platense, La Plata

B1900AXI

Hospital Italiano de La Plata, La Plata

B1704ETD

DIM Clinica Privada, Ramos Mejía

14785-002

Faculdade de Medicina Barretos FACISB, Barretos

30130-100

Universidade Federal De Minas Gerais - Hospital das Clínicas, Belo Horizonte

30150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

70200 730

L2IP Instituto de Pesquisas Clinicas, Brasília

13060-904

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro, Campinas

778606-715

Fundacao Universidade Federal de Mato Grosso do Sul, Campo Grande

88811-508

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose, Criciúma

78043-142

Oncovida - Centro de Onco-Hematologia de Mato Grosso, Cuiabá

80810-040

Hospital Nossa Senhora Das Gracas, Curitiba

59025-050

Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

91350 200

Hospital Nossa Senhora da Conceicao S A, Porto Alegre

14040 900

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP, Ribeirão Preto

20221-160

Ministerio da Saude - Hospital dos Servidores do Estado - RJ, Rio de Janeiro

20241-180

Instituto Brasil de Pesquisa Clinica, Rio de Janeiro

21040-900

Fundacao Oswaldo Cruz, Rio de Janeiro

26030-380

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu, Rio de Janeiro

40110-060

Fundacao Bahiana De Infectologia, Salvador

09521-160

Universidade Municipal de Sao Caetano do Sul, São Caetano do Sul

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base, São José do Rio Preto

01228-000

CPQuali Pesquisa Clinica LTDA ME, São Paulo

01246-900

Instituto de infectologia Emilio Ribas, São Paulo

01308 901

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo

01323 900

Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo

02141-000

Centro de Referencia E Treinamento Dst/Aids, São Paulo

04266-010

CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos, São Paulo

05403 000

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

47811-51

Hospital Dr Hernan Henriquez Aravena, Temuco

080001

Clinica de la Costa, Barranquilla

080020

Centro de Reumatologia y Ortopedia, Barranquilla

00000

Centro de Atencion e Investigacion Medica S.A. - CAIMED, Bogotá

Programa de Estudio y Control de Enfermedades Tropicales, Medellín

050034

Hospital Pablo Tobon Uribe, Medellín

Unknown

Fundacion Centro de Investigacion Clinica CIC, Medellín

Synexus Watermeyer, Pretoria

06720

Centro Medico Nacional Siglo XXI IMSS, México

06750

CAIMED Investigacion en salud S.A de C.V., México

CP 22010

Infectolab, Tijuana

0000

Centro de Invetigaciones Medicas, Callao

02

Hospital Nacional Daniel Alcides Carrion, Callao

07066

Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM), Callao

LIMA 01

Asociacion Civil Via Libre, Lima

LIMA12

Instituto de Investigacion Nutricional, Lima

LIMA32

Asociacion Civil Impacta Salud y Educacion- San Miguel CRS, Lima

Barranco 15063

Asociacion Civil Impacta Salud y Educacion - Barranco, Lima - Barranco

0485

Ndlovu Elandsdoorn Site, Dennilton

0122

Stanza Clinical Research Centre : Mamelodi, Mamelodi East

0204

MeCRU Clinical Research Unit, Pretoria

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

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