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HVTN 117/HPX2004/IPCAVD011/TRAVERSE

Status
Ongoing
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.

Prevention Option(s)
HIV Vaccine
Study Design
Double-blind
Arms and Assigned Interventions
Description
Participants 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 Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
ARMs
Experimental
Clade
C
Description
Placebo Comparator: Group 1B: Placebo Participants will receive placebo at Weeks 0, 12, 24 and 48.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants 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 Delivery
Intramuscular
Products
Ad26.Mos.HIV
ARMs
Experimental
Clade
C
Description
Placebo Comparator: Group 2B: Placebo Participants will receive placebo at Weeks 0, 12, 24 and 48.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
Janssen, HVTNNIAID, MHRP, BIDMC, Ragon
June 2016
May 2018
Enrollment
198
18
Years
50
Years
Population
Women
Men
Sites

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

Brigham and Women's Hospital CRS

Boston, Massachusetts
United States of America

Columbia P&S CRS

New York, NY
United States of America

Fenway Health (FH) CRS

Boston, Massachusetts
United States of America

Site(s) - Nashville

Nashville, Tennessee
United States of America

New York Blood Center

New York, New York
United States of America

Site(s) - Philadelphia

Philadelphia, Pennsylvania
United States of America

University of Rochester HVTN CRS

Rochester, New York
United States of America

Site(s) - San Francisco

San Francisco, California
United States of America

Site(s) - Seattle

Seattle, Washington
United States of America

Kigali

Rwanda