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HIV-V-A004/IPCAVD 009 (APPROACH)

Status
Ongoing
Phase
I/II
Objective

The purpose of this study (CR106152, HIV-V-A004, IPCAVD009) is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.

Prevention Option(s)
HIV Vaccine
Arms and Assigned Interventions
Description
Participants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) 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
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + placebo injection at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by modified Vaccinia Ankara (MVA)-Mosaic vaccine + gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + placebo injection at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant + placebo injection at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Description
Participants will receive 1 placebo injection at Week 0 and 12; followed by 2 placebo injections at Week 24 and 48.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
MVA
ARMs
Experimental
Clade
C
Trial Sponsors
Crucell Holland BV; Collaborators include: US National Institute of Allergy and Infectious Diseases Division of AIDS (US NIAID); US Military HIV Research Program (US MHRP); Beth Israel Deaconess Medical Center; International AIDS Vaccine Initiative (IAVI)
December 2014
April 2019
Enrollment
400
18
Years
50
Years
Population
Women
Men
Sites

Aurora, Colorado

United States of America

Miami, Florida

United States of America

Austin, Texas

United States of America

Rockville, Maryland

United States of America

Boston, Massachusetts

United States of America

Kigali

Rwanda

Cape Town

South Africa

Durban

South Africa

Johannesburg

South Africa

Soweto

South Africa

Bangkok

Thailand

Entebbe

Uganda

Kampala

Uganda