HVTN 117/ HPX2004/ IPCAVD011/ TRAVERSE

Status:Completed
Phase:I/II
Principal Investigator(s):Janssen Vaccines & Prevention B.V. Clinical Trial
Objective:The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed. 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.Mos.HIV vaccine at Week 0 and 12, followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum 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 + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT02788045
Related Publications:
Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study
Trial Sponsors: and Janssen Vaccines & Prevention, Bill & Melinda Gates Foundation, Harvard, Henry M Jackson Foundation, MIT, NIH, Ragon Institute of MGH
Start Date
End Date
July 1, 2016
April 1, 2023
Enrollment:198
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women