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HPX2003/HVTN118/IPCAVD012/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.

Prevention Option(s)
HIV Vaccine
Study Design
Double-blind
Arms and Assigned Interventions
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 (aluminium phosphate) at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
ARMs
Experimental
Clade
C
Description
Participants 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 Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
ARMs
Experimental
Clade
C
Description
Participants will receive a single placebo injection at Weeks 0 and 12, followed by two placebo injections at Weeks 24 and 48.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
Janssen, HVTNNIAID, MHRP, BIDMC, Ragon
March 2017
January 2019
Enrollment
150
18
Years
50
Years
Sites

Site(s) - Atlanta

Atlanta, GA
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 Institute

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