HVTN 119/ p24CE1/2 pDNA
Status:Completed
Phase:I
Principal Investigator(s):Spyros Kalams
Objective:The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
last updated February 24, 2021
Prevention Option(s):HIV Vaccine
Study Design:Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive the p24CE1/2 pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Month 1. They will receive the p24CE1/2 pDNA vaccine plus the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Months 1, 3, and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT03181789
Trial Sponsors:
NIAID (DAIDS-ES: 12061)
Start Date
End Date
October 18, 2017
April 29, 2020
Enrollment:56
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women