- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486408
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Alabama Vaccine CRS
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Vaccines to Prevent HIV Infection CRS
-
-
Tennessee
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Nashville, Tennessee, United States, 37232-2582
- Vanderbilt Vaccine (VV) CRS
-
-
Washington
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Seattle, Washington, United States, 98109-1024
- Seattle Vaccine and Prevention CRS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
MRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26
|
1.5x10^10 Ad vg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relatedness of different immune response to vaccine
Time Frame: Throughout study
|
Throughout study
|
Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine
Time Frame: Throughout study
|
Throughout study
|
Characterization of different functions of T cells that have responded to the vaccine
Time Frame: Throughout study
|
Throughout study
|
Safety and tolerability of three doses of vaccine
Time Frame: Throughout study
|
Throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in physical features of certain immune cells in response to the vaccine
Time Frame: Throughout study
|
Throughout study
|
Indications of an immune response to the vaccine
Time Frame: Throughout study
|
Throughout study
|
Presence of T cells in the genital tract
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HVTN 071
- 10503 (Registry Identifier: DAIDS-ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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