Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00850616
First received: February 24, 2009
Last updated: March 25, 2011
Last verified: March 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Merck:
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 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:
|
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 May 19, 2013