A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)

Study Overview
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Brief Summary
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This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.

Official Title
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A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults

Conditions
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HIV-1, HIV Infections

Intervention / Treatment
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* Biological: V520
* Biological: Comparator: V520 (1x10^9 vp/d)
* Biological: Comparator: V520 (1x10^10 vp/d)
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good general health Subject tests negative for Hepatitis B, Hepatitis C, and HIV Subjects of reproductive potential agree to use an accepted method of birth control through the entire study Exclusion Criteria: Subject has a recent history of fever at time of vaccination Subject has received immune globulin or blood product 3 months prior to injection Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose Subject has a chronic medical condition that is considered progressive Subject has history of malignancy Subject weighs less than 105 lb. Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study Subject has contraindication to intramuscular injection Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera

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>V520 (1x10^9 vp/d) | Biological: V520<br>* Intentionally Blank<br>Biological: Comparator: V520 (1x10^9 vp/d)<br>* 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26<br>|
| Experimental: 2<br>V520 (1x10^10 vp/d) | Biological: Comparator: V520 (1x10^10 vp/d)<br>* 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26<br>|
| Placebo Comparator: 3<br>Placebo to V520 | Biological: Comparator: Placebo<br>* Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at 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 prime-boost regimen of MRKAd5 HIV-1 gag vaccine |  | 4 weeks after third vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breadth of immune response measured by several assays |  | 4 weeks after third vaccination | 

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