Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants

Completed · Phase 1

Conditions studied: HIV-1 Infection, HIV Infections

In brief

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.

Key facts

Study ID: NCT01082692
Run by: Inovio Pharmaceuticals
People needed: 12
Starts: 2011-01-01
Expected to finish: 2012-08-01
Last updated by the study team: 2012-11-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Hemoglobin > 9 g/dL (female subjects) > 9.5 g/dL (male subjects)
Absolute neutrophil count > 1000 cells/μL
Platelet count > 75,000/μL
ALT, AST and alkaline phosphatase < 2.5 x upper limit of normal range
Total bilirubin < 2.5 x upper limit of the laboratory normal range
Serum creatinine <1.5 mg/dL X upper limit of normal (ULN)
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

You may not qualify if…

Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma
History of a CD4+ T-cell count ≤200/μL
Grade 2 or higher CPK laboratory result
Use of any known immunomodulatory therapy within 4 weeks prior to study entry
Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed
Pregnancy or breast-feeding
Uncontrolled diabetes mellitus
Major organ transplantation
Active alcohol or substance abuse or psychiatric illness, which in the opinion of the investigator will interfere with adherence to study requirements
Clinically significant neurological disorder occurring within 1 year prior to study entry
Use of systemic corticosteroids for 4 weeks within 3 months prior to study entry
Presence of any chronic disease that in the opinion of the investigator might affect subject safety
History of previous vaccination with an HIV-1 vaccine except where documentation of placebo is available
History of cardiac arrhythmia
History or evidence of autoimmune disease
Allergies to bupivacaine or similar anesthetic
Metal implants at the site of injection
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness
Any other conditions judged by the investigator that would limit the evaluation of a subject

Where it is running

University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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