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

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

Official Title
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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

Conditions
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HIV, HIV Infections

Intervention / Treatment
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* Biological: V526
* Biological: Comparator: Placebo to V526


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MRKAd6 Trigene 0.5x10^9 Ad6 vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 2<br>MRKAd6 Trigene 0.5x10^10 Ad6 vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 3<br>MRKAd6 Trigene 0.5x10^11 Ad6 vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 4<br>MRKAd5 Trigene 0.5x10^10 Ad5 vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 5<br>MRKAd5 Trivalent 1.5x10^10 Ad5 vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 6<br>MRKAd5+6 Trigene 1x10^9 Ad vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Experimental: 7<br>MRKAd5+6 Trigene 1x10^10 Ad vg | Biological: V526<br>* 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.<br>|
| Placebo Comparator: 8<br>Placebo | Biological: Comparator: Placebo to V526<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs |  | Week 30 | 
| Immune response to MRKAd5+6 trigene vaccine |  | 30 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6 |  | Week 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Seronegativity, Preventive Vaccine