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HVTN 119

Status
Ongoing
Phase
I
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.

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Arms and Assigned Interventions
Description
Participants 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 Delivery
Intramuscular
Products
DNA plasmid
ARMs
Experimental
Description
Participants in Group 1 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants will receive the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Months 1, 3, and 6.
Mode of Delivery
Intramuscular
Products
DNA plasmid
ARMs
Experimental
Description
Participants in Group 2 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
DAIDS
July 2017
October 2019
Enrollment
56
18
Years
45
Years
Sites

Site(s) - Cleveland

Cleveland, OH
United States of America

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America

Site(s) - San Francisco

San Francisco, California
United States of America