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

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ClinicalTrials.gov Identifier: NCT00850616
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date November 2, 2015
Study Start Date  ICMJE April 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
  • Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs [ Time Frame: Week 30 ]
  • Immune response to MRKAd5+6 trigene vaccine [ Time Frame: 30 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00850616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6 [ Time Frame: Week 30 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • HIV Infections
Intervention  ICMJE
  • Biological: V526
    0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
  • Biological: Comparator: Placebo to V526
    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.
Study Arms  ICMJE
  • Experimental: 1
    MRKAd6 Trigene 0.5x10^9 Ad6 vg
    Intervention: Biological: V526
  • Experimental: 2
    MRKAd6 Trigene 0.5x10^10 Ad6 vg
    Intervention: Biological: V526
  • Experimental: 3
    MRKAd6 Trigene 0.5x10^11 Ad6 vg
    Intervention: Biological: V526
  • Experimental: 4
    MRKAd5 Trigene 0.5x10^10 Ad5 vg
    Intervention: Biological: V526
  • Experimental: 5
    MRKAd5 Trivalent 1.5x10^10 Ad5 vg
    Intervention: Biological: V526
  • Experimental: 6
    MRKAd5+6 Trigene 1x10^9 Ad vg
    Intervention: Biological: V526
  • Experimental: 7
    MRKAd5+6 Trigene 1x10^10 Ad vg
    Intervention: Biological: V526
  • Placebo Comparator: 8
    Placebo
    Intervention: Biological: Comparator: Placebo to V526
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2011)
147
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2009)
146
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00850616
Other Study ID Numbers  ICMJE V526-001
2009_551
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP