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HVTN 108

Status
Ongoing
Phase
I/II
Principal Investigator(s)
Nigel Garrett
Objective

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

 

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Arms and Assigned Interventions
Description
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Mode of Delivery
Intramuscular
Products
DNA plasmid
gp120
ARMs
Experimental
Clade
C
Description
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Mode of Delivery
Intermuscular
Products
DNA plasmid
gp120
ARMs
Experimental
Clade
C
Description
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Mode of Delivery
Intramuscular
Products
DNA plasmid
gp120
ARMs
Experimental
Clade
C
Description
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Mode of Delivery
Intramuscular
Products
DNA plasmid
gp120
ARMs
Experimental
Clade
C
Description
Group 8
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
December 2016
October 2019
Enrollment
334
18
Years
40
Years
Population
Women
Men
Sites

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

University of Rochester HVTN CRS

Rochester, New York
United States of America

Site(s) - Seattle

Seattle, Washington
United States of America

Site(s) - Bara

Soweto
South Africa

Emavundleni (EMA) CRS

Cape Town
South Africa

eThekwini CRS

Durban, KwaZulu-Natal
South Africa

Klerksdorp

South Africa

Soshanguve

South Africa

The Aurum Institute, Tembisa Hospital

Tembisa
South Africa

Site(s) - Ladysmith

South Africa

Kliptown

Soweto
South Africa

Verulam CRS

Verulam, KwaZulu-Natal
South Africa