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

Phase 1

Completed

• Conditions: HIV-1; HIV Infections
• Interventions: Biological: V520

• Registration Number: NCT00849732
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-10
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Study Completion: 2011-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	V520	V520 (1x10\^9 vp/d)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine	4 weeks after third vaccination

Secondary Outcome Measures

Name	Time	Method
breadth of immune response measured by several assays	4 weeks after third vaccination