HVTN 118/ HPX 2003/ IPCAVD-012/ ASCENT
Status:Ongoing
Phase:I/II
Principal Investigator(s):Janssen Vaccines & Prevention B.V. Clinical Trial
Objective:The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens. Heterologous vaccination regimens including Ad26 and gp140 have conferred significant protection in NHP, and were safe and immunogenic in humans.
To optimize breadth, and refine the vaccine composition, ASCENT assessed adding Mosaic1 gp140 to clade C gp140 in the regimen.Results: (Presented at IAS 2019) Results demonstrate that 2 investigational mosaic-based prophylactic vaccine regimens intended to prevent HIV-1 infection induced high immune responses against a broad range of virus strains. Both regimens were well tolerated and immunogenic. ASCENT supports using bivalent clade C-Mosaic1 gp140 with Ad26.Mos4.HIV for expanded clade coverage in the phase 3 efficacy study trial starting in 2019.Last updated September 14, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12, followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminium phosphate) at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + combination of 125 mcg Mosaic gp140 and 125 mcg Clade C gp140 mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT02935686
Trial Sponsors:
BIDMC, HVTN, Janssen, MHRP, NIAID, Ragon
Start Date
End Date
March 31, 2017
December 4, 2023
Enrollment:155
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women