A5281
Status:Completed
Phase:I
Principal Investigator(s):Jeffrey Jacobson, MD Division of Infectious Diseases and HIV Medicine, Drexel University
Objective:Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of giving the vaccine called electroporation (EP).
Prevention Option(s):Therapeutic Vaccines
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionHIV MAG pDNA injection followed by electroporation.
Biological: Profectus HIV MAG pDNA vaccine
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and
12
Biological: IL-12 - Administered at Weeks 0, 4, and 12
Mode of DeliveryIntramuscular
ARMs
DescriptionHIV MAG pDNA plus 1,000 mcg of IL-12 pDNA injection followed by electroporation. Biological: Profectus HIV MAG pDNA vaccine
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and
12
Biological: IL-12 - Administered at Weeks 0, 4, and 12
Mode of DeliveryIntramuscular
ARMs
DescriptionHIV MAG pDNA plus 250 mcg of IL-12 pDNA injection followed by electroporation. Biological: Profectus HIV MAG pDNA vaccine
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and
12
Biological: IL-12 - Administered at Weeks 0, 4, and 12
Mode of DeliveryIntramuscular
ARMs
DescriptionHIV MAG pDNA plus 50 mcg of IL-12 pDNA injection followed by electroporation. Biological: Profectus HIV MAG pDNA vaccine
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and
12
Biological: IL-12 - Administered at Weeks 0, 4, and 12
Mode of DeliveryIntramuscular
ARMs
DescriptionHIV MAG pDNA plus 1,000 mcg (or highest dose reached) IL-12 pDNA injections. Biological: Profectus HIV MAG pDNA vaccine
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and
12
Biological: IL-12 - Administered at Weeks 0, 4, and 12
Mode of DeliveryIntramuscular
ARMs
Official Code:
NCT01266616
Trial Sponsors:
NIAID
Start Date
End Date
March 31, 2011
none
Enrollment:62
Age range:
18 Years ↔
55 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV