HVTN 706/ HPX3002/ Mosaico

Status:Ongoing
Phase:III
Principal Investigator(s):
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 in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States..Last updated September 13, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionParticipants 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 DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive placebo into the deltoid on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Mode of DeliveryIntramuscular
ARMsPlacebo Comparator
Official Code: NCT03964415
Related Publications:
NIH and partners to launch HIV vaccine efficacy trial in the Americas and Europe
W26052102 Imbokodo & Mosaico updates, plans for correlates and sieve analyses
Trial Sponsors: Janssen Vaccines & Prevention B.V.
Start Date
End Date
October 31, 2019
March 13, 2024
Enrollment:3,900
Age range: 18 Years ↔ 60 Years
Population:Cisgender Men