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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	HIV Vaccine Trials Network
Information provided by (Responsible Party):	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00486408

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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

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
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Washington
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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:

Click here for more information about preventive HIV vaccines This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. Review.

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. Epub 2004 Sep 30.

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.

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:	March 29, 2012
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 May 24, 2012