Back to resultsStudy of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants (HIV-001)
Primary Purpose
HIV-1 Infection, HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PENNVAX-B
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV Infection, DNA vaccine, Electroporation, HIV therapeutic vaccine
Eligibility 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3mg DNA/dose
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety and tolerability
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
Magnitude of HIV-specific immune response as determined by ELISpot assay measured two weeks following the 4th vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01082692
Brief Title
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
Acronym
HIV-001
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inovio Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, HIV Infections
Keywords
HIV Infection, DNA vaccine, Electroporation, HIV therapeutic vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3mg DNA/dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PENNVAX-B
Intervention Description
DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
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.
Time Frame
Day 0 through Week 48
Secondary Outcome Measure Information:
Title
T-cell responses
Description
Magnitude of HIV-specific immune response as determined by ELISpot assay measured two weeks following the 4th vaccination
Time Frame
Day 0 through Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Tebas, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
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