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Ensayos clínicos

Ensayos clínicos

Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-uninfected, Circumcised Men

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00865566, HVTN 505
  • En curso, con inscripciones cerradas

Propósito del estudio

The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men who have sex with men.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people

were living with HIV/AIDS globally. The US HIV prevalence data reported in October 2008 by

the Centers for Disease Control and Prevention estimates that 1.1 million adults and

adolescents were living with diagnosed or undiagnosed HIV infection in the United States at

the end of 2006. Nearly half of all US HIV infections (48.1%) were found in men who have sex

with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission

over a lifetime and the occurrence of non-consensual sex, the need for a safe and effective

vaccine is clear. The primary purpose of this study is to determine the safety and efficacy

of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised MSM.



Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive

a recombinant DNA plasmid vaccine injection at study entry and on Days 28, and 56, followed

by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm

2 will receive placebo injections at study entry and on Days 28, 56, and 168.



This is an event-driven study. Participants will be tested for HIV approximately every 3

months until a sufficient number of HIV infections have accumulated for assessment of the

primary endpoints.



Participants who do not become HIV-infected will be actively followed for a minimum of 12

months and will continue to be contacted by the study for long-term safety surveillance for a

total of 5 years following enrollment. Participants will be contacted annually during the

period of long-term safety surveillance.



Participants who become HIV-infected prior to the primary evaluation time point and primary

data analysis will be followed for 18 months post-diagnosis. Participants who are infected

after that point will be offered follow-up through another study.In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people

were living with HIV/AIDS globally. The US HIV prevalence data reported in October 2008 by

the Centers for Disease Control and Prevention estimates that 1.1 million adults and

adolescents were living with diagnosed or undiagnosed HIV infection in the United States at

the end of 2006. Nearly half of all US HIV infections (48.1%) were found in men who have sex

with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission

over a lifetime and the occurrence of non-consensual sex, the need for a safe and effective

vaccine is clear. The primary purpose of this study is to determine the safety and efficacy

of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised MSM.



Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive

a recombinant DNA plasmid vaccine injection at study entry and on Days 28, and 56, followed

by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm

2 will receive placebo injections at study entry and on Days 28, 56, and 168.



This is an event-driven study. Participants will be tested for HIV approximately every 3

months until a sufficient number of HIV infections have accumulated for assessment of the

primary endpoints.



Participants who do not become HIV-infected will be actively followed for a minimum of 12

months and will continue to be contacted by the study for long-term safety surveillance for a

total of 5 years following enrollment. Participants will be contacted annually during the

period of long-term safety surveillance.



Participants who become HIV-infected prior to the primary evaluation time point and primary

data analysis will be followed for 18 months post-diagnosis. Participants who are infected

after that point will be offered follow-up through another study.

Criterios de inclusión

    :
    • HIV-1 and -2 negative
    • Good general health
    • Fully circumcised
    • Anal intercourse within 24 weeks prior to study entry. More information on this
    criterion can be found in the protocol.
    • ALT less than 2.6 times the upper limit of normal (ULN)
    • Ad5 nAb titer less than 1:18
    • Have access to a participating study site and are willing to be followed during the
    study
    • Demonstrate understanding of the study
    • Willing to receive HIV test results
    • Willing to discuss HIV infection risks and amenable to risk reduction counseling

Criterios de exclusión

    :
    • HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation
    that they received a placebo in a prior HIV trial may be eligible.
    • Used PEP more than 2 times within 12 months or has used PEP within 60 days prior to
    first vaccination
    • Used PrEP more than 5 times within 6 months or for 30 consecutive days within 60 days
    prior to first vaccination
    • Circumcised within 90 days prior to first vaccination or displays evidence that
    surgical site is not fully healed
    • Immunosuppressive medications within 168 days prior to first study vaccination.
    Participants who have used corticosteroid nasal sprays for allergic rhinitis, topical corticosteroids for mild, uncomplicated dermatitis, or oral/parenteral corticosteroids for non-chronic conditions are not excluded.
    • Blood products within 90 days prior to first study vaccination
    • Immunoglobulin within 90 days prior to first study vaccination
    • Live attenuated vaccines within 30 days prior to first study vaccination
    • Investigational research agents within 90 days prior to first study vaccination
    • Any vaccines that are not live attenuated within 14 days prior to first study
    vaccination
    • Allergy treatment with antigen injections within 30 days prior to first study
    vaccination or that are scheduled within 14 days after first vaccination
    • Clinically significant medical condition, abnormal physical exam findings, abnormal
    laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
    • Any medical, psychiatric, or job-related responsibility that would interfere with the
    study. More information about this criterion can be found in the protocol.
    • Any concern that, in the opinion of the investigator, may interfere with a
    participant's completion of the post-vaccination symptom log
    • History of anaphylaxis or allergy to any of the vaccine's components
    • Autoimmune disease
    • Immunodeficiency
    • Bleeding disorder
    • History of malignancy
    • Seizure disorder
    • Asthma other than mild, well-controlled asthma. More information on this criterion can
    be found in the protocol.
    • Angioedema within the last 3 years if episodes are considered serious or have required
    medication within the last 2 years prior to study entry

Centros de estudio/contactos

Alabama

    Alabama CRS, Birmingham, Alabama, 35294, United States

California

    The AIDS Research Alliance of America CRS, Los Angeles, California, 90015, United States

    Bridge HIV CRS, San Francisco, California, 94143, United States

Colorado

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

Florida

    Orlando Immunology Center HVTN CRS, Orlando, Florida, 32803, United States

Georgia

    The Hope Clinic of the Emory Vaccine Center CRS, Decatur, Georgia, 30030, United States

Illinois

    UIC Project WISH CRS, Chicago, Illinois, 60612, United States

Maryland

    VRC Clinical Trials Core CRS, Bethesda, Maryland, 20816, United States

Massachusetts

    Fenway Health (FH) CRS, Boston, Massachusetts, 02215-4302, United States

    Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston, Massachusetts, 02115-6110, United States

New York

    New York Blood Center CRS, New York, New York, 10065, United States

    NY Univ. HIV/AIDS CRS, New York, New York, 10016, United States

    Columbia P&S CRS, New York, New York, 10032-3732, United States

    University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester, New York, 14642, United States

Ohio

    Case CRS, Cleveland, Ohio, 44106, United States

Pennsylvania

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

Tennessee

    Vanderbilt Vaccine (VV) CRS, Nashville, Tennessee, 37232-2582, United States

Texas

    University of Texas Southwestern CRS, Dallas, Texas, 75235, United States

    Baylor Vaccine Research Center CRS, Houston, Texas, 77030, United States

Virginia

    Care-Id Crs, Annandale, Virginia, 22003, United States

Washington

    Seattle Vaccine and Prevention CRS, Seattle, Washington, 98109-1024, United States

Actualizado: 29 de agosto del 2013

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