CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
HIV-1 gag DNA +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00115960
NCT00115960Phase 1Completed

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Gag DNA Vaccine Alone or With IL-15 DNA, Boosted With HIV-1 Gag DNA + IL-15 DNA or HIV-1 Gag DNA + IL-12 DNA, in Healthy, HIV-1 Uninfected Adult Participants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 27, 2005·Updated Oct 14, 2021

In Brief

A Phase 1 clinical trial evaluating HIV-1 gag DNA, IL-15 DNA adjuvant, and 1 other intervention for HIV Infections. Completed, enrolled 120 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2005
Study CompletionJul 1, 2008
TodayJul 2, 2026
Posted 21.0 years ago

Interventions

HIV-1 gag DNAbiological

DNA vaccine containing the HIV gene gag

IL-15 DNA adjuvantbiological

Cytokine injection

IL-12 DNA adjuvantbiological

Cytokine injection