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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00850616
First received: February 24, 2009
Last updated: November 13, 2014
Last verified: November 2014

February 24, 2009
November 13, 2014
April 2005
August 2006   (final data collection date for primary outcome measure)
  • Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
  • Immune response to MRKAd5+6 trigene vaccine [ Time Frame: 30 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00850616 on ClinicalTrials.gov Archive Site
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • HIV
  • HIV Infections
  • 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.
  • 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
Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, Dinubile MJ, Quirk E; for the 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):1285-1292. Epub 2009 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
March 2011
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00850616
V526-001, 2009_551
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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