A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

PHASE3CompletedINTERVENTIONAL
Enrollment

3,900

Participants

Timeline

Start Date

October 31, 2019

Primary Completion Date

August 10, 2023

Study Completion Date

August 10, 2023

Conditions
Healthy
Interventions
BIOLOGICAL

Ad26.Mos4.HIV

Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.

BIOLOGICAL

Clade C and Mosaic gp140 HIV bivalent vaccine

Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.

BIOLOGICAL

Placebo

Participants will receive matching placebo.

Trial Locations (53)

10027

Harlem Prevention Center CRS, New York

10032

Columbia University Medical Center, New York

10065

New York Blood Center, New York

14000

Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran, Mexico City

14004

Hosp Reina Sofia, Córdoba

14642

Strong Memorial Infectious Disease, Rochester

15001

Asociacion Civil Via Libre, Lima

15088

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

16001

Asociacion Civil Selva Amazonica (ACSA), Iquitos

19104

University of Pennsylvania, Philadelphia

20127

Ospedale San Raffaele, Milan

20816

Whitman Walker Health, Washington D.C.

28015

Hosp Univ Fund Jimenez Diaz, Madrid

28040

Hosp. Clinico San Carlos, Madrid

30030

The Hope Clinic at Emory University, Decatur

30322

Emory University Rollins School of Public Health - Ponce De Leon CRS, Atlanta

32803

Orlando Immunology Center, Orlando

33136

University of Miami, Miami

35222

University of Alabama at Birmingham, Birmingham

37212

Vanderbilt University Medical Center, Nashville

41124

Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena

44280

Hospital Civil Fray Antonio Alcalde, Guadalajara

46014

Hosp. Gral. Univ. Valencia, Valencia

60612

University Of Illinois, Chicago

70112

New Orleans Adolescent Trials Unit CRS, New Orleans

77098

Gordon E. Crofoot MD, Houston

94102

Bridge HIV, San Francisco

97000

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

98104

Seattle Vaccine Trials Unit, Seattle

02115

Dana-Farber/Brigham and Women's Hospital, Boston

02215

Fenway Health, Boston

07103

Rutgers, The State University of New Jersey - The University Hospital/ACTG Network, Newark

C1141ACG

Helios Salud Sa, Buenos Aires

C1202ABB

Fundacion Huesped, Ciudad Autonoma de Buenos Aire

C1221Adc

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

S2000PBJ

Instituto Caici Srl., Rosario

30130-100

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

80810-050

Centro Medico Sao Francisco, Curitiba

69040-000

Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT, Manaus

21040-900

Fundacao Oswaldo Cruz, Rio de Janeiro

26030-380

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

01246-900

Instituto de infectologia Emilio Ribas, São Paulo

01246-903

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

02141-000

Centro de Referencia E Treinamento Dst/Aids, São Paulo

00149

Istituto nazionale malattie infettive 'L. Spallanzani', Roma

07066

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

Barranco 15063

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

80-462

Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska, Gdansk

50-136

Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza, Wroclaw

00909

Clinical Research Puerto Rico Inc, San Juan

00936-5067

University of Puerto Rico, San Juan

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08001

Hosp. Univ. Vall D Hebron, Barcelona

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT03964415 - A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals | Biotech Hunter | Biotech Hunter