Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

October 31, 2016

Conditions
HIV Infections
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

Placebo

Placebo will consist of sodium chloride for injection, USP 0.9%.

DEVICE

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.

Trial Locations (5)

10065

New York Blood Center CRS, New York

14642

University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester

19104

Penn Prevention CRS, Philadelphia

10032-3732

Columbia P&S CRS, New York

37232-2582

Vanderbilt Vaccine (VV) CRS, Nashville

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01578889 - Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults | Biotech Hunter | Biotech Hunter