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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.
Full description
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.
Enrollment
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Inclusion criteria
HIV-1 infection
On a stable HAART regimen for ≥3 months before the time of enrollment
CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment
HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment
Body mass index (BMI) ≤30 kg/m^2
Laboratory values obtained within 30 days prior to study entry:
Female subjects of reproductive potential must have a negative serum pregnancy test performed within 30 days of initiating the protocol-specified vaccination and a negative urine pregnancy test at Day 0 (enrollment)
Ability and willingness of subject or legal guardian/representative to give written informed consent
Exclusion criteria
Primary purpose
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Interventional model
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12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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