Trial record 9 of 27 for:    " May 29, 2007":" June 29, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults

This study has been completed.
Sponsor:
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00486408
First received: June 12, 2007
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults.


Condition Intervention Phase
HIV Infections
Biological: MRKAd5 HIV-1 gag/pol/nef
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relatedness of different immune response to vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Characterization of different functions of T cells that have responded to the vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Safety and tolerability of three doses of vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in physical features of certain immune cells in response to the vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Indications of an immune response to the vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Presence of T cells in the genital tract [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2007
Study Completion Date: November 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26
Biological: MRKAd5 HIV-1 gag/pol/nef
1.5x10^10 Ad vg

Detailed Description:

This study will look for relationships among the immune responses induced by MRKAd5 HIV-1 gag/pol/nef vaccine. The study will also determine if the T cells that respond to different vaccine epitopes have correspondingly different functional profiles. The study will evaluate the safety and tolerability of the vaccine regimen as well.

This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks 0, 4, and 26. There will be between 8 and 20 study visits including the screening visit, depending on the site location. A physical exam, interview, and blood collection will occur at most or all visits. All participants will undergo leukapheresis approximately 4 weeks after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test, and HIV and risk reduction counseling will occur at selected visits. Additional blood collection is now occurring in this study to collect more information about the relationship between the immune response and efficacy to the vaccine.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Note: As of 09/19/07, enrollment and vaccinations have been discontinued.

Inclusion Criteria:

  • Good general health
  • HIV uninfected
  • Weight of 110 pounds or greater
  • Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
  • Willing to receive HIV test results
  • Understand the vaccination procedure
  • Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit

Exclusion Criteria:

  • HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
  • Immunosuppressive medications within 168 days prior to first study vaccination
  • Blood products within 90 days prior to first study vaccination or within 14 days after the injection
  • Immunoglobulin within 90 days prior to first study vaccination or within 14 days after the injection
  • Live attenuated vaccines within 42 days prior to first study vaccination or within 14 days after the injection
  • Investigational research agents within 30 days prior to first study vaccination
  • Medically indicated subunit or killed vaccines within 5 days prior to first study vaccination or within 14 days after the injection
  • Allergy treatment with antigen injections within 30 days prior to first study vaccination
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with the study.
  • History of anaphylaxis and/or allergy to vaccine components
  • Autoimmune disease or immunodeficiency
  • Uncontrolled hypertension
  • Bleeding disorder
  • Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
  • Seizure disorder
  • Absence of the spleen
  • Abnormal laboratory values
  • Mental illness that would interfere with the study
  • Hysterectomy
  • Pregnancy or breastfeeding
  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: NCT00486408

Locations
United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, New York
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States, 37232-2582
United States, Washington
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
HIV Vaccine Trials Network
Investigators
Study Chair: Ann Duerr, MD, PhD, MPH HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)
Study Chair: Mike Keefer, MD University of Rochester
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00486408     History of Changes
Other Study ID Numbers: HVTN 071, 10503
Study First Received: June 12, 2007
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine
Adenovirus

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Adenoviridae Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on July 20, 2014