Study of PENNVAXâ„¢-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
| Status: | Archived |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
A Phase I, Open Label Study to Evaluate the Safety, Tolerability and Immunogenicity of PENNVAXâ„¢-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
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.
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.
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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