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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01082692
First received: March 5, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
HIV-1 Infection
HIV Infections
 Biological: PENNVAX-B
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082692

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Principal Investigator: Pablo Tebas, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01082692     History of Changes
Other Study ID Numbers: HIV-001
Study First Received: March 5, 2010
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Inovio Pharmaceuticals:
HIV Infection
DNA vaccine
Electroporation
HIV therapeutic vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013