IAVI B004

Status:Completed
Phase:I
Principal Investigator(s):Susan Buchbinder, Christine (Mhorag) Hay
Objective:To evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionHIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionHIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)
Mode of DeliveryIntramuscular
ARMsExperimental
Results: A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vacc
Official Code: NCT01496989
Related Publications:
Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial
Trial Sponsors: IAVI, Ichor Medical Systems, Profectus Biosciences
Start Date
End Date
December 1, 2011
March 31, 2013
Enrollment:75
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women