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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MRKAd5 HIV-1 gag/pol/nef

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine, Adenovirus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Alabama Vaccine CRS
University of Rochester Vaccines to Prevent HIV Infection CRS
Vanderbilt Vaccine (VV) CRS
Seattle Vaccine and Prevention CRS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Relatedness of different immune response to vaccine

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

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

Safety and tolerability of three doses of vaccine

Secondary Outcome Measures

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

Indications of an immune response to the vaccine

Presence of T cells in the genital tract

Full Information

NCT ID

NCT00486408

First Posted

June 12, 2007

Last Updated

October 13, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

HIV Vaccine Trials Network

1. Study Identification

Unique Protocol Identification Number

NCT00486408

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

HIV Vaccine Trials Network

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Seronegativity, HIV Preventive Vaccine, Adenovirus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

MRKAd5 HIV-1 gag/pol/nef

Intervention Description

1.5x10^10 Ad vg

Primary Outcome Measure Information:

Title

Relatedness of different immune response to vaccine

Time Frame

Throughout study

Title

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

Time Frame

Throughout study

Title

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

Time Frame

Throughout study

Title

Safety and tolerability of three doses of vaccine

Time Frame

Throughout study

Secondary Outcome Measure Information:

Title

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

Time Frame

Throughout study

Title

Indications of an immune response to the vaccine

Time Frame

Throughout study

Title

Presence of T cells in the genital tract

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Duerr, MD, PhD, MPH

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mike Keefer, MD

Organizational Affiliation

University of Rochester

Official's Role

Study Chair

Facility Information:

Facility Name

Alabama Vaccine CRS

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

University of Rochester Vaccines to Prevent HIV Infection CRS

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Vanderbilt Vaccine (VV) CRS

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-2582

Country

United States

Facility Name

Seattle Vaccine and Prevention CRS

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-1024

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15761255

Citation

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.

Results Reference

background

PubMed Identifier

15478077

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. doi: 10.1086/424490. Epub 2004 Sep 30.

Results Reference

background

PubMed Identifier

17147493

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. doi: 10.1089/aid.2006.22.1081.

Results Reference

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

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