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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT01266616, ACTG A5281
  • En curso, con inscripciones cerradas

Propósito del estudio

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.

Afección:Fase:
Infecciones por el VIH
Fase 1

Detalles del estudio

Although highly active antiretroviral therapy (HAART) has greatly reduced HIV infection

related morbidity and mortality, individual response to therapy can be variable. Therapeutic

vaccination works by augmenting virus-specific immunity and can be given with or without

immunomodulatory agents or adjuvants. In conjunction with HAART, therapeutic vaccination may

be a more effective treatment for the suppression of HIV-1 replication. This study will

examine the safety and efficacy of giving an investigational vaccine with or without IL-12

in HIV-1 infected adults receiving HAART. This study will also test whether delivering the

vaccine using electroporation is safe and increases the efficacy of the vaccine.



Participation in this study will last approximately 36 weeks. Participants will be randomly

assigned to 1 of 5 cohorts. Cohort 1 will receive the HIV multi-antigen plasmid DNA (HIV MAG

pDNA) vaccine or placebo in the upperarm followed by electroporation (IM/EP). Cohorts 2-4

will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX IL-12

pDNA or placebo by IM/EP. Cohort 5 will receive the HIV MAG pDNA vaccine with the highest

dose of IL-12 pDNA or placebo by needle and syringe in the upper arm.



Participants receive two injections at Weeks 0, 4, and 12. Participants will complete a

questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30

minutes for observation after each vaccination. Participants will be contacted by telephone

2-3 days post-vaccination to assess vaccination-related signs and/or symptoms. All

participants will be asked to record their temperatures and any symptoms they experience

daily for 4 days following each vaccination on a Vaccination Report Card (VRC). All

non-study vaccines or medications should also be recorded on the VRC. Participants will

undergo a physical examination at each study visit (Weeks 0, 1, 4, 6, 8, 12, 14, 16, 24, and

36). Women of reproductive potential will also undergo pregnancy testing before receiving

injections on Weeks 0, 4, and 12. Blood will be drawn at various time points to evaluate

participants' health and measure immunologic markers, CD4 and CD8 T cell counts, and

cytokine levels. Blood and plasma will also be stored for future exploratory studies.Although highly active antiretroviral therapy (HAART) has greatly reduced HIV infection

related morbidity and mortality, individual response to therapy can be variable. Therapeutic

vaccination works by augmenting virus-specific immunity and can be given with or without

immunomodulatory agents or adjuvants. In conjunction with HAART, therapeutic vaccination may

be a more effective treatment for the suppression of HIV-1 replication. This study will

examine the safety and efficacy of giving an investigational vaccine with or without IL-12

in HIV-1 infected adults receiving HAART. This study will also test whether delivering the

vaccine using electroporation is safe and increases the efficacy of the vaccine.



Participation in this study will last approximately 36 weeks. Participants will be randomly

assigned to 1 of 5 cohorts. Cohort 1 will receive the HIV multi-antigen plasmid DNA (HIV MAG

pDNA) vaccine or placebo in the upperarm followed by electroporation (IM/EP). Cohorts 2-4

will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX IL-12

pDNA or placebo by IM/EP. Cohort 5 will receive the HIV MAG pDNA vaccine with the highest

dose of IL-12 pDNA or placebo by needle and syringe in the upper arm.



Participants receive two injections at Weeks 0, 4, and 12. Participants will complete a

questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30

minutes for observation after each vaccination. Participants will be contacted by telephone

2-3 days post-vaccination to assess vaccination-related signs and/or symptoms. All

participants will be asked to record their temperatures and any symptoms they experience

daily for 4 days following each vaccination on a Vaccination Report Card (VRC). All

non-study vaccines or medications should also be recorded on the VRC. Participants will

undergo a physical examination at each study visit (Weeks 0, 1, 4, 6, 8, 12, 14, 16, 24, and

36). Women of reproductive potential will also undergo pregnancy testing before receiving

injections on Weeks 0, 4, and 12. Blood will be drawn at various time points to evaluate

participants' health and measure immunologic markers, CD4 and CD8 T cell counts, and

cytokine levels. Blood and plasma will also be stored for future exploratory studies.

Criterios de inclusión

    :
    • HIV-1 infected
    • Stable 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 entry)
    • 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 of reproductive potential are eligible without requiring the use of a
    contraceptive
    • Ability and willingness of subject or legal guardian/representative to provide
    written informed consent
    • Collection of a pre-entry PBMC specimen for immunologic assays and entered into the
    Laboratory Data Management System (LDMS)

Criterios de exclusión

    :
    • 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 one 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
    entry
    • 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 prilocaine
    • 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 defibrillator, nerve stimulators, or deep brain stimulators
    • 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)

Centros de estudio/contactos

California

    UCLA CARE Center CRS, Los Angeles, California, 90035, United States

    Stanford AIDS Clinical Trials Unit CRS, Palo Alto, California, 94304-5350, United States

    Ucsf Hiv/Aids Crs, San Francisco, California, 94110, United States

Colorado

    University of Colorado Hospital CRS, Aurora, Colorado, 80045, United States

Massachusetts

    Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS, Boston, Massachusetts, 02114, United States

    Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston, Massachusetts, 02115, United States

Missouri

    Washington University Therapeutics (WT) CRS, St. Louis, Missouri, 63110, United States

New York

    Univ. of Rochester ACTG CRS, Rochester, New York, 14642, United States

    Trillium Health ACTG CRS, Rochester, New York, 14607, United States

Ohio

    Cincinnati CRS, Cincinnati, Ohio, 45219, United States

Pennsylvania

    Penn Therapeutics Crs, Philadelphia, Pennsylvania, 19104, United States

    University of Pittsburgh CRS, Pittsburgh, Pennsylvania, 15213-2582, United States

Texas

    Houston AIDS Research Team CRS, Houston, Texas, 77030, United States

Actualizado: 24 de febrero del 2012

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