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CompletedNCT00486408Updated Oct 14, 2021

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

A Phase 1 interventional study of MRKAd5 HIV-1 gag/pol/nef in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV Infections

Keywords

  • HIV Seronegativity
  • HIV Preventive Vaccine
  • Adenovirus
03

In context

Adenoviridae Infections

104 studies on the registry are indexed under Adenoviridae Infections; 32 are open to participants now.

This study's enrollment of 35 is close to the median of 36 across 80 interventional studies indexed under Adenoviridae Infections.

Browse Adenoviridae Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Inclusion criteria

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalMRKAd5 HIV-1 gag/pol/nef

    1.5x10\^10 Ad vg

06

What researchers measure

Primary outcomes

  1. Relatedness of different immune response to vaccine

    Time frame: Throughout study

  2. Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine

    Time frame: Throughout study

  3. Characterization of different functions of T cells that have responded to the vaccine

    Time frame: Throughout study

  4. Safety and tolerability of three doses of vaccine

    Time frame: Throughout study

Secondary outcomes

  1. Changes in physical features of certain immune cells in response to the vaccine

    Time frame: Throughout study

  2. Indications of an immune response to the vaccine

    Time frame: Throughout study

  3. Presence of T cells in the genital tract

    Time frame: Throughout study

07

Study locations

4 sites
  • Alabama Vaccine CRS
    Birmingham, Alabama 35294, United States
  • University of Rochester Vaccines to Prevent HIV Infection CRS
    Rochester, New York 14642, United States
  • Vanderbilt Vaccine (VV) CRS
    Nashville, Tennessee 37232-2582, United States
  • Seattle Vaccine and Prevention CRS
    Seattle, Washington 98109-1024, United States
08

References and documents

Publications

  • Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149. PubMed 15761255 ↗
  • Horton H, Russell N, Moore E, Frank I, Baydo R, Havenar-Daughton C, Lee D, Deers M, Hudgens M, Weinhold K, McElrath MJ. Correlation between interferon- gamma secretion and cytotoxicity, in virus-specific memory T cells. J Infect Dis. 2004 Nov 1;190(9):1692-6. doi: 10.1086/424490. Epub 2004 Sep 30. PubMed 15478077 ↗
  • Tobery TW, Dubey SA, Anderson K, Freed DC, Cox KS, Lin J, Prokop MT, Sykes KJ, Mogg R, Mehrotra DV, Fu TM, Casimiro DR, Shiver JW. A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV Type 1 gag vaccinated human subjects. AIDS Res Hum Retroviruses. 2006 Nov;22(11):1081-90. doi: 10.1089/aid.2006.22.1081. PubMed 17147493 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00486408
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
HIV Vaccine Trials Network
Responsible party
Sponsor
First posted
Jun 14, 2007
Start date
Jul 2007
Primary completion
Sep 2008
Completion
Nov 2012
Last update
Oct 14, 2021

Study contacts

Ann Duerr, MD, PhD, MPH
study chair · HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)
Mike Keefer, MD
study chair · University of Rochester
View the source record on ClinicalTrials.gov ↗

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