Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults

Not Recruiting

Trial ID: NCT01266616


Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of giving the vaccine called electroporation (EP).

Official Title

A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART

Stanford Investigator(s)

Philip Grant
Philip Grant

Assistant Professor of Medicine (Infectious Diseases)


Inclusion Criteria:

   - HIV-1 infected

   - Stable antiretroviral therapy (ART) for a minimum of 6 consecutive months prior to
   study entry and intention to remain on stable ART until study completion

   - CD4 T-cell count greater than or equal to 500 cells/mm3 (within 30 days prior to study

   - At least two measurements of HIV-1 RNA levels less than or equal to 200 copies/mL
   (first measurement must be performed at least 6 months prior to study entry and second
   measurement must be performed between 6 months prior to study entry and at least 30
   days prior to study entry)

   - Screening HIV-1 RNA less than 50 copies/mL (within 30 days prior to study entry)

   - Hepatitis B surface antigen negative (within 30 days prior to study entry)

   - Hepatitis C antibody negative or, if hepatitis C antibody positive, hepatitis C virus
   RNA negative (within 30 days prior to study entry)

   - Certain laboratory values obtained within 30 days prior to study entry; more
   information can be found in the protocol

   - Females of reproductive potential must have a negative urine pregnancy test within 3
   days prior to study entry

   - All study participants participating in sexual activity that could lead to pregnancy
   must agree to use at least one of the following forms of birth control for at least 21
   days prior to study entry until the final study visit:

      - Condoms (male or female) with or without a spermicidal agent

      - Diaphragm or cervical cap with spermicide

      - Intrauterine device (IUD)

      - Hormone-based contraceptive

   - Females who are not of reproductive potential are eligible without requiring the use
   of a contraceptive

   - Ability and willingness of subject to provide written informed consent

   - Collection of a pre-entry PBMC specimen for immunologic assays and entered into the
   Laboratory Data Management System (LDMS)

Exclusion Criteria:

   - Confirmed (defined as two consecutive values) CD4 T-cell count less than 200 cells/mm3
   at any time or any history or subject recollection of CD4 T-cell count less than 200
   cells/mm3 prior to screening

   - Any active malignancy that may require chemotherapy or radiation therapy

   - Bleeding diathesis or condition associated with prolonged bleeding time that would
   contraindicate IM injection

   - A skin-fold measurement of the cutaneous and subcutaneous tissue for eligible
   injection sites (on the medial deltoid muscles) that exceeds 40 mm

   - Use of immunomodulatory, cytokine, or growth stimulating factors such as systemic
   corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody,
   granulocyte macrophage colony-stimulating factor (GM-CSF), chondrocyte
   colony-stimulating factor (C-CSF), IFN, or interleukin-2 (IL-2) (within 30 days prior
   to study entry)

   - Pregnancy or breastfeeding

   - Use of any prior HIV vaccine (prophylactic and/or therapeutic) within 1 year before
   study entry

   - Use of any investigational treatment within 6 months before study entry

   - Use of any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza,
   pneumococcal polysaccharide) within 4 weeks prior to study entry

   - Use of any infusion blood product or immune globulin within 3 months prior to study

   - Known or suspected hypersensitivity to any vaccine component, including
   hypersensitivity to amide-type local anesthetics, such as lidocaine (Xylocaine),
   mepivacaine (Polocaine/Carbocaine), etidocaine (Duranest), bupivacaine (Marcaine), or

   - Active drug or alcohol use or dependence that, in the opinion of the site
   investigator, would interfere with adherence to study requirements

   - Serious illness requiring systemic treatment and/or hospitalization within 7 days
   prior to study entry

   - Current use of any electronic stimulation device, such as cardiac demand pacemakers,
   automatic implantable cardiac defibrillators, nerve stimulators, or deep brain

   - History of cardiac arrhythmia or palpitations (e.g., supraventricular tachycardia,
   atrial fibrillation, frequent ectopy, or sinus bradycardia [i.e., <50 beats per minute
   on exam]) prior to study entry (NOTE: Sinus arrhythmia is not excluded)

   - History of syncope or fainting episode within 1 year of study entry

   - Seizure disorder or any history of prior seizure

   - Extensive tattoos covering the site of administration (upper left and right medial
   deltoid muscles)

   - Presence of any surgical or traumatic metal implants at the site of administration
   (medial deltoid muscles)

   - Any chronic inflammatory disease (e.g., ankylosing spondylitis, psoriasis,
   inflammatory bowel disease)


biological: Profectus HIV MAG pDNA vaccine

biological: IL-12

other: Placebo

biological: Profectus HIV MAG pDNA vaccine

biological: IL-12

other: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305