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

NCT ID: NCT00486408

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-11-30

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

MRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26

Group Type: EXPERIMENTAL

MRKAd5 HIV-1 gag/pol/nef

Intervention Type: BIOLOGICAL

1.5x10\^10 Ad vg

Interventions

MRKAd5 HIV-1 gag/pol/nef

1.5x10\^10 Ad vg

Intervention Type: BIOLOGICAL

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HIV Vaccine Trials Network

NETWORK

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Duerr, MD, PhD, MPH

Role: STUDY_CHAIR

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

Mike Keefer, MD

Role: STUDY_CHAIR

University of Rochester

Locations

Alabama Vaccine CRS

Birmingham, Alabama, United States

University of Rochester Vaccines to Prevent HIV Infection CRS

Rochester, New York, United States

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, United States

Seattle Vaccine and Prevention CRS

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15761255 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15478077 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17147493 (View on PubMed)

Other Identifiers

10503

Identifier Type: REGISTRY

Identifier Source: secondary_id

HVTN 071

Identifier Type: -

Identifier Source: org_study_id