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

About this trial
This is an interventional prevention trial for HIV focused on measuring HIV, HIV Seronegativity, Preventive Vaccine
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
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
NCT ID
NCT00850616
First Posted
February 24, 2009
Last Updated
October 30, 2015
Sponsor
Merck Sharp & Dohme LLC
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
Learn more about this trial
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
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