HVTN 098
Status:Completed
Phase:I
Principal Investigator(s):Srilatha Edupuganti
Objective:The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
*Trial is in follow-up*
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Group 1: Treatment
Participants will receive the PENNVAX®-GP vaccine 0.6 mg admixed with IL-12 DNA 0.2 mg to be administered as 0.1 mL by intradermal (ID) injection over either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Mode of DeliveryIntradermal
ARMsExperimental
DescriptionExperimental: Group 2: Treatment
Participants will receive the PENNVAX®-GP vaccine 0.8 mg to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Mode of DeliveryIntradermal
ARMsExperimental
DescriptionExperimental: Group 3: Treatment
Participants will receive the PENNVAX®-GP vaccine 0.8 mg admixed with IL-12 DNA 0.2 mg to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Mode of DeliveryIntradermal
ARMsExperimental
DescriptionExperimental: Group 4: Treatment
Participants will receive the PENNVAX®-GP vaccine 8 mg admixed with IL-12 DNA 1 mg to be administered as 1 mL intramuscular (IM) injection in either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 5P EP system.
Mode of DeliveryIntradermal
ARMsExperimental
Official Code:
NCT02431767
Trial Sponsors:
NIAID
Start Date
End Date
August 9, 2016
August 2, 2016
Enrollment:94
Age range:
18 Years ↔
55 Years
Population:Cisgender Men, Cisgender Women