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HPX3002/HVTN 706: Mosaico

Status
Ongoing
Phase
III
Objective

The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.

 

Last updated February 3, 2020.

Prevention Option(s)
HIV Vaccine
Study Design
Placebo-controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid at Months 6 and 12 (different deltoid for each injection).
Mode of Delivery
Intramuscular
Products
Ad26.Mos4.HIV
gp140
ARMs
Experimental
Clade
C/Mosaic
Description
Participants will receive placebo into the deltoid on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
ARMs
Placebo Comparator
Trial Sponsors
Janssen Vaccines & Prevention B.V.
June 2019
June 2023
Enrollment
3 800
18
Years
60
Years
Population
Men
Sites

Whitman Walker Clinic

Washington, D.C.
United States of America

Gordon E. Crofoot MD

Houston, Texas
United States of America

Helios Salud Sa

Buenos Aires
Argentina

Fundacion Huesped

Buenos Aires
Argentina

Instituto Caici Srl.

Rosario
Argentina

Ospedale San Raffaele

Milano
Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena
Italy

Istituto nazionale malattie infettive 'L. Spallanzani'

Rome
Italy

Hospital Civil Fray Antonio Alcalde

Guadalajara
Mexico

Unidad de Atención Medica e Investigacion en Salud (UNAMIS)

Merida
Mexico

Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran

Mexico City
Mexico

Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran

Mexico City
Mexico

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

Callao
Peru

Asociación Civil Selva Amazónica (ACSA)

Iquitos
Peru

Asociacion Civil Impacta Salud y Educacion - Barranco

Lima
Peru

Asociacion Civil Impacta Salud y Educacion- San Miguel CRS

Lima
Peru

Asociacion Civil Via Libre

Lima
Peru

Centrum PrEP

Gdansk
Poland

Chmielna Express

Warszawa
Poland

SP ZOZ Wroclawskie Centrum Zdrowia

Wroclaw
Poland

Hosp. Univ. Germans Trias I Pujol

Badalona
Spain

Hosp. Univ. Vall D Hebron

Barcelona
Spain

Hosp. Reina Sofia

Cordoba
Spain

Hosp. Univ. Fund. Jimenez Diaz

Madrid
Spain

Hosp. Clinico San Carlos

Madrid
Spain

Hosp. Gral. Univ. Valencia

Valencia
Spain