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

October 30, 2015 updated by: Merck Sharp & Dohme LLC

A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MRKAd6 Trigene 0.5x10^9 Ad6 vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 2
MRKAd6 Trigene 0.5x10^10 Ad6 vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 3
MRKAd6 Trigene 0.5x10^11 Ad6 vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 4
MRKAd5 Trigene 0.5x10^10 Ad5 vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 5
MRKAd5 Trivalent 1.5x10^10 Ad5 vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 6
MRKAd5+6 Trigene 1x10^9 Ad vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Experimental: 7
MRKAd5+6 Trigene 1x10^10 Ad vg
Biological: V526
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Placebo Comparator: 8
Placebo
Biological: Comparator: Placebo to V526
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
Time Frame: Week 30
Week 30
Immune response to MRKAd5+6 trigene vaccine
Time Frame: 30 week
30 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
Time Frame: Week 30
Week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V526-001
  • 2009_551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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