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Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V526
Comparator: Placebo to V526
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
  • Subject agrees to use an acceptable method of birth control through week 52 of the study

Exclusion Criteria:

  • Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
  • Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
  • Subject has known or suspected impaired immune function
  • Subject has participated in any other HIV vaccine trial
  • Female subject is pregnant or breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    6

    7

    8

    Arm Description

    MRKAd6 Trigene 0.5x10^9 Ad6 vg

    MRKAd6 Trigene 0.5x10^10 Ad6 vg

    MRKAd6 Trigene 0.5x10^11 Ad6 vg

    MRKAd5 Trigene 0.5x10^10 Ad5 vg

    MRKAd5 Trivalent 1.5x10^10 Ad5 vg

    MRKAd5+6 Trigene 1x10^9 Ad vg

    MRKAd5+6 Trigene 1x10^10 Ad vg

    Placebo

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
    Immune response to MRKAd5+6 trigene vaccine

    Secondary Outcome Measures

    Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6

    Full Information

    First Posted
    February 24, 2009
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00850616
    Brief Title
    Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
    Official Title
    A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, HIV Infections
    Keywords
    HIV, HIV Seronegativity, Preventive Vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MRKAd6 Trigene 0.5x10^9 Ad6 vg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    MRKAd6 Trigene 0.5x10^10 Ad6 vg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    MRKAd6 Trigene 0.5x10^11 Ad6 vg
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    MRKAd5 Trigene 0.5x10^10 Ad5 vg
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    MRKAd5 Trivalent 1.5x10^10 Ad5 vg
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    MRKAd5+6 Trigene 1x10^9 Ad vg
    Arm Title
    7
    Arm Type
    Experimental
    Arm Description
    MRKAd5+6 Trigene 1x10^10 Ad vg
    Arm Title
    8
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Biological
    Intervention Name(s)
    V526
    Intervention Description
    0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo to V526
    Intervention Description
    0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
    Time Frame
    Week 30
    Title
    Immune response to MRKAd5+6 trigene vaccine
    Time Frame
    30 week
    Secondary Outcome Measure Information:
    Title
    Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
    Time Frame
    Week 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection Subject agrees to use an acceptable method of birth control through week 52 of the study Exclusion Criteria: Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine Subject has known or suspected impaired immune function Subject has participated in any other HIV vaccine trial Female subject is pregnant or breastfeeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19605598
    Citation
    Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15.
    Results Reference
    result

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    Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)

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