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

NCT00486408 | Completed Phase 1

• 2 other identifiers: HVTN 07110503
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV Infections

Keywords

HIV Seronegativity; HIV Preventive Vaccine; Adenovirus

Outcome Measures

Primary Outcomes (4)

• Relatedness of different immune response to vaccine

  Throughout study

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

  Throughout study

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

  Throughout study

• Safety and tolerability of three doses of vaccine

  Throughout study

Secondary Outcomes (3)

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

  Throughout study

• Indications of an immune response to the vaccine

  Throughout study

• Presence of T cells in the genital tract

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

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

MRKAd5 HIV-1 gag/pol/nef BIOLOGICAL

1.5x10\^10 Ad vg

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• HIV Vaccine Trials Network: collaborator

Study Sites (4)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

University of Rochester Vaccines to Prevent HIV Infection CRS

Rochester, New York, 14642, United States

Location

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, 37232-2582, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98109-1024, United States

Location

Related Publications (3)

• 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.

  PMID: 15761255 BACKGROUND

• 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.

  PMID: 15478077 BACKGROUND

• 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.

  PMID: 17147493 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections

Study Officials

• Ann Duerr, MD, PhD, MPH

  HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)

  STUDY CHAIR

• Mike Keefer, MD

  University of Rochester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2012
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (4)