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

Phase 1

Completed

• Conditions: HIV Infections; HIV

• 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

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-08
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Completion: 2011-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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