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: October 13, 2014
Last verified: October 2014

June 12, 2007
October 13, 2014
July 2007
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Relatedness of different immune response to vaccine, with the potential for application of the results to larger vaccine trials
  • The features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine, as found by a technique called flow cytometry
  • Characterization of different functions of T-cell that have responded to the vaccine
  • Safety and tolerability of three doses of vaccine given by injections in the muscle
Complete list of historical versions of study NCT00486408 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in physical features of certain immune cells in response to the vaccine
  • Indications of an immune response to the vaccine by changes in the way some genes are expressed
  • Presence in the blood of small molecules called cytokines that indicate an immune response to the vaccine
  • Presence of T-cells in the genital tract that are primed to respond specifically to HIV after injection of the vaccine into the muscle
Not Provided
Not Provided
 
Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Biological: MRKAd5 HIV-1 gag/pol/nef
1.5x10^10 Ad vg
Experimental: 1
MRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26
Intervention: Biological: MRKAd5 HIV-1 gag/pol/nef

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
November 2012
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00486408
HVTN 071, 10503
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
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
National Institute of Allergy and Infectious Diseases (NIAID)
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP