CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 62 enrolled
Drug / intervention
Profectus HIV MAG pDNA vaccine +2 morebiological
Likely dose
Profectus HIV MAG pDNA vaccine 3,000 mcgfrom 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/NCT01266616
NCT01266616Phase 1Completed
CompareCT.gov

A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 24, 2010·Updated Nov 1, 2021

In Brief

A Phase 1 clinical trial evaluating Profectus HIV MAG pDNA vaccine, IL-12, and 1 other intervention for HIV Infections. Completed, enrolled 62 participants across 13 sites.

Detailed Summary

Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of giving the vaccine called electroporation (EP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartMar 1, 2011
Primary CompletionOct 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.5 years ago

Interventions

Profectus HIV MAG pDNA vaccinebiological

3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and 12

IL-12biological

Administered at Weeks 0, 4, and 12

Placeboother

Saline injections at Weeks 0, 4, and 12