Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

Not specified

Study Completion Date

May 31, 2008

Conditions
HIV Infections
Interventions
BIOLOGICAL

HIV-1 gag DNA

A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid

BIOLOGICAL

HIV-1 gag DNA plus IL-12 DNA adjuvant

Injection IL-12 DNA adjuvant intramuscularly into the deltoid

BIOLOGICAL

CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)

A 1 mL intramuscular injection in the deltoid

BIOLOGICAL

Sodium chloride injection (0.9%)

"All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.~Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273."

Trial Locations (4)

21201

Project Brave HIV Vaccine CRS, Baltimore

37232

Vanderbilt Vaccine CRS, Nashville

35294-2041

Alabama Vaccine CRS, Birmingham

Unknown

Chiang Mai Univ. HVTN CRS, Chiang Mai

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00111605 - Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults | Biotech Hunter | Biotech Hunter