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

NCT01082692 | Completed Phase 1 DMC

• 1 other identifier: HIV-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection; HIV Infections

Keywords

HIV Infection; DNA vaccine; Electroporation; HIV therapeutic vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 through Week 48

Secondary Outcomes (1)

• T-cell responses

  Day 0 through Week 48

Study Arms (1)

3mg DNA/dose

EXPERIMENTAL

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

Interventions

PENNVAX-B BIOLOGICAL

DNA plasmids delivered via IM injection + electroporation using CELLECTRA device

3mg DNA/dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Pablo Tebas, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

US (1)