Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
Phase 1
Completed
- Conditions
- HIV InfectionsHIV
- Interventions
- Biological: V526
- Registration Number
- NCT00850616
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 V526 MRKAd5+6 Trigene 1x10\^9 Ad vg 7 V526 MRKAd5+6 Trigene 1x10\^10 Ad vg 2 V526 MRKAd6 Trigene 0.5x10\^10 Ad6 vg 1 V526 MRKAd6 Trigene 0.5x10\^9 Ad6 vg 4 V526 MRKAd5 Trigene 0.5x10\^10 Ad5 vg 5 V526 MRKAd5 Trivalent 1.5x10\^10 Ad5 vg 3 V526 MRKAd6 Trigene 0.5x10\^11 Ad6 vg
- Primary Outcome Measures
Name Time Method Immune response to MRKAd5+6 trigene vaccine 30 week Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs Week 30
- Secondary Outcome Measures
Name Time Method Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6 Week 30