Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

Study Overview
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Brief Summary
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This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.

Official Title
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A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
* Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
* Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates good general health Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative Low risk of acquiring HIV infection ALT lab value within normal range Exclusion Criteria: Previously received an investigational HIV vaccine Has a known or suspected impairment of immunologic function Has a clinically significant chronic medical condition that is considered progressive Has a major psychiatric illness Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer Weighs less than 105 lbs. Has a recent (within two years) history of chronic alcohol abuse Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study Male subject is planning to impregnate or provide sperm donation during the study

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: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose<br>MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)<br>* 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.<br>* Other names: V520;|
| Experimental: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose<br>MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)<br>* 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.<br>* Other names: V520;|
| Experimental: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose<br>MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)<br>* 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.<br>* Other names: V520;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks |  | 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS