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Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants (HIV-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082692
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection HIV Infections Biological: PENNVAX-B Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Biological: PENNVAX-B
DNA plasmids delivered via IM injection + electroporation using CELLECTRA device

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Day 0 through Week 48 ]
    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.

Secondary Outcome Measures :
  1. T-cell responses [ Time Frame: Day 0 through Week 48 ]
    Magnitude of HIV-specific immune response as determined by ELISpot assay measured two weeks following the 4th vaccination

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082692

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
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Principal Investigator: Pablo Tebas, MD University of Pennsylvania
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Responsible Party: Inovio Pharmaceuticals Identifier: NCT01082692    
Other Study ID Numbers: HIV-001
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Keywords provided by Inovio Pharmaceuticals:
HIV Infection
DNA vaccine
HIV therapeutic vaccine
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases