Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants (HIV-001)
DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. We have developed DNA vaccine, PENNVAX-B, which includes plasmids targeting the gag, pol, and env proteins of HIV-1. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to HIV-1 infected subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above 400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well tolerated.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open Label Study to Evaluate the Safety, Tolerability and Immunogenicity of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants|
- Safety and tolerability [ Time Frame: Day 0 through Week 48 ] [ Designated as safety issue: Yes ]Frequency and severity of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, including CD4 and HIV RNA viral load changes, and adverse and serious adverse events.
- T-cell responses [ Time Frame: Day 0 through Week 48 ] [ Designated as safety issue: No ]Magnitude of HIV-specific immune response as determined by ELISpot assay measured two weeks following the 4th vaccination
|Study Start Date:||January 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: 3mg DNA/dose
Subjects will receive a 4 dose series of PENNVAX-B containing 3mg of DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8 and Week 16.
DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
A single group of approximately 12 HIV-infected subjects will receive a 4 dose series of PENNVAX-B containing 3 mg of DNA/dose at study entry (Day 0), Week 4, 8, 16 and will be followed for a total of 48 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082692
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Pablo Tebas, MD||University of Pennsylvania|