334
Participants
Start Date
December 7, 2016
Primary Completion Date
August 7, 2019
Study Completion Date
February 12, 2020
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
"Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose."
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Kliptown Soweto CRS, Johannesburg
The Aurum Institute Tembisa Clinical Research Centre CRS, Johannesburg
Soweto HVTN CRS, Johannesburg
Aurum Institute Klerksdorp CRS, Klerksdorp
Qhakaza Mbokodo Research Clinic CRS, Ladysmith
CAPRISA eThekwini CRS, Durban
Verulam CRS, Verulam
Emavundleni CRS, Cape Town
New York Blood Center CRS, New York
University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester
Alabama CRS, Birmingham
Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston
Fenway Health (FH) CRS, Boston
Columbia P&S CRS, New York
Vanderbilt Vaccine (VV) CRS, Nashville
Seattle Vaccine and Prevention CRS, Seattle
Setshaba Research Centre CRS, Soshanguve
National Institute of Allergy and Infectious Diseases (NIAID)
NIH