Trial record 19 of 41 for:    " February 18, 2009":" March 20, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00850616
First received: February 24, 2009
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Biological: V526
Biological: Comparator: Placebo to V526
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 147
Study Start Date: April 2005
Study Completion Date: March 2011
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MRKAd6 Trigene 0.5x10^9 Ad6 vg
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.
Experimental: 2
MRKAd6 Trigene 0.5x10^10 Ad6 vg
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.
Experimental: 3
MRKAd6 Trigene 0.5x10^11 Ad6 vg
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.
Experimental: 4
MRKAd5 Trigene 0.5x10^10 Ad5 vg
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.
Experimental: 5
MRKAd5 Trivalent 1.5x10^10 Ad5 vg
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.
Experimental: 6
MRKAd5+6 Trigene 1x10^9 Ad vg
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.
Experimental: 7
MRKAd5+6 Trigene 1x10^10 Ad vg
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.
Placebo Comparator: 8
Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850616

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00850616     History of Changes
Other Study ID Numbers: 2009_551, V526-001
Study First Received: February 24, 2009
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HIV
HIV Seronegativity
Preventive Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014