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

Merck Sharp & Dohme LLC147 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

147

Conditions

HIV HIV Infections

Interventions

V526BIOLOGICAL

0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.

Comparator: Placebo to V526BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs

Time frame: Week 30

Immune response to MRKAd5+6 trigene vaccine

Time frame: 30 week

Secondary Outcomes

Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6

Time frame: Week 30

Data from ClinicalTrials.gov

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