100
Participants
Start Date
May 31, 2012
Primary Completion Date
September 30, 2014
Study Completion Date
October 31, 2016
HIV-MAG vaccine
Participants assigned to receive the HIV-MAG vaccine will receive 3 mg of the vaccine with bupivacaine, alone or admixed with one of three doses of the IL-12 pDNA adjuvant.
IL-12 pDNA adjuvant
Participants assigned to receive the IL-12 plasmid (IL-12 pDNA) adjuvant will receive one of three doses (total of 250 mcg, 1000 mcg, or 1500 mcg) of the adjuvant admixed with the HIV-MAG vaccine.
VSV HIV gag vaccine
Participants assigned to receive the VSV HIV gag vaccine will receive a total dose of 1x10\^8 plaque-forming units (PFUs) administered as 5x10\^7 PFU in 1 mL by IM injection in both the left and right deltoids at Month 6.
Placebo
Placebo will consist of sodium chloride for injection, USP 0.9%.
Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
The HIV-MAG vaccine, IL-12 pDNA adjuvant, and placebos for IL-12 pDNA adjuvant/HIV-MAG vaccines will be delivered IM into the deltoid by the Ichor Medical Systems TDS EP device.
New York Blood Center CRS, New York
University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester
Penn Prevention CRS, Philadelphia
Columbia P&S CRS, New York
Vanderbilt Vaccine (VV) CRS, Nashville
National Institute of Allergy and Infectious Diseases (NIAID)
NIH