HVTN 087

Status:Completed
Phase:I
Principal Investigator(s):Christine (Mhorag) Hay, University of Rochester
Objective:To evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults. last updated March 27, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine administered as 0.5 mL by intramuscular (IM) injection in both the left and right deltoids using the Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 250 mcg IL-12 pDNA adjuvant, and divided into two 0.55 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1,000 mcg of the IL-12 pDNA adjuvant and divided into two 0.75 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1500 mcg of the IL-12 pDNA adjuvant divided into two 0.9 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01578889
Related Publications:
Rational design of a plasmid DNA vaccine capable of eliciting cell-mediated immune responses to multiple HIV antigens in mice.
Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo ele
Combined effects of IL-12 and electroporation enhances the potency of DNA vaccination in macaques.
In vivo biodistribution of a highly attenuated recombinant vesicular stomatitis virus expressing HIV-1 Gag following intramuscul
Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers
DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8 + T-Cell Responses by Interleukin-12 Plasmid DNA
Trial Sponsors: NIAID
Start Date
End Date
May 31, 2012
September 30, 2014
Enrollment:100
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women