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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486408
• Other study ID #: HVTN 071
• Secondary ID: 10503
• Status: Completed
• Phase: Phase 1
• Start date: July 2007
• Est. completion date: November 2012

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2012
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoviridae Infections
• HIV Infections

Intervention

Biological:
• MRKAd5 HIV-1 gag/pol/nef
1.5x10^10 Ad vg

Locations

Country	Name	City	State
United States	Alabama Vaccine CRS	Birmingham	Alabama
United States	Vanderbilt Vaccine (VV) CRS	Nashville	Tennessee
United States	University of Rochester Vaccines to Prevent HIV Infection CRS	Rochester	New York
United States	Seattle Vaccine and Prevention CRS	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	HIV Vaccine Trials Network

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relatedness of different immune response to vaccine		Throughout study
Primary	Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine		Throughout study
Primary	Characterization of different functions of T cells that have responded to the vaccine		Throughout study
Primary	Safety and tolerability of three doses of vaccine		Throughout study
Secondary	Changes in physical features of certain immune cells in response to the vaccine		Throughout study
Secondary	Indications of an immune response to the vaccine		Throughout study
Secondary	Presence of T cells in the genital tract		Throughout study

External Links

•   Click here for more information about preventive HIV vaccines
•   Haga clic aquí para ver información sobre este ensayo clínico en español.