Clinical Trials

MainTitle

Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00107549

First received: April 5, 2005
Last updated: May 17, 2012
Last Verified: May 2012
History of Changes
Purpose

Purpose

The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.

Condition Intervention Phase
HIV Infections

Biological : rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
Biological : rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy (HAART)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Development of any adverse events of Grade 3 or higher [ Time Frame: Throughout study ]
  • Development of adverse events of Grade 3 or higher attributed to the study vaccines [ Time Frame: Throughout study ]
  • Viral breakthrough to greater than 1,000 copies/ml [ Time Frame: During the first 24 weeks of study ]

Enrollment: 20
Study Completion Date: February 2009

Arms Assigned Interventions
Experimental: 1
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
Biological: rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])

Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4

Biological: rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])

Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24

Detailed Description:

By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.
This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and two rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and

    ne collection will occur at study entry and Weeks 4, 8, and 24.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 24 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • HIV-1 infected
    • CD4 count of 350 cells/mm3 or greater
    • If hepatitis B or C infected, infection must be chronic and stable
    • Normal electrocardiogram (ECG)
    • On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry
    • Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination.
    • Willing to follow all study requirements
    • Available for follow-up for the duration of the study


    Exclusion Criteria:
    • History of allergic reaction to eggs or egg products
    • Known hypersensitivity to vaccine components
    • Chemotherapy for active cancer in the 12 months prior to study entry
    • Prior vaccination with any HIV-1 vaccine
    • Prior vaccination against smallpox
    • Prior vaccinia immunization
    • Any immunization within 1 month of study screening
    • History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care
    • Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry
    • Systemic steroids, including nonprescription street steroids, within 6 months of study entry
    • Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition
    • Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study
    • Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study
    • Pregnancy or breastfeeding

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00107549

    Locations

    United States, California
    Children's Hospital Los Angeles NICHD CRS
    Los Angeles, California, United States, 90027
    Usc La Nichd Crs
    Los Angeles, California, United States, 90033
    United States, Colorado
    Univ. of Colorado Denver NICHD CRS
    Aurora, Colorado, United States, 80218-1088
    United States, Illinois
    Chicago Children's CRS
    Chicago, Illinois, United States, 60614
    United States, Maryland
    Univ. of Maryland Baltimore NICHD CRS
    Baltimore, Maryland, United States
    United States, New York
    Columbia IMPAACT CRS
    New York, New York, United States
    United States, North Carolina
    DUMC Ped. CRS
    Durham, North Carolina, United States
    United States, Tennessee
    St. Jude/UTHSC CRS
    Memphis, Tennessee, United States, 38105-2794
    Puerto Rico
    Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
    San Juan, Puerto Rico

    Sponsors and Collaborators

    National Institute of Allergy and Infectious Diseases (NIAID)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    Study Chair: Coleen K. Cunningham, MD Pediatric Infectious Diseases, Duke University
    More Information

    More Information


    Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
    ClinicalTrials.gov Identifier: NCT00107549   History of Changes  
    Other Study ID Numbers: P1059  
      10051  
      PACTG P1059  
    Study First Received: April 5, 2005  
    Last Updated: May 17, 2012  

    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

    Treatment Experienced
    HIV Therapeutic Vaccine

    Additional relevant MeSH terms:
    HIV Infections
    Vaccines

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.