NCT00850616

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1 hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

February 24, 2009

Last Update Submit

October 30, 2015

Conditions

HIVHIV Infections

Keywords

HIVHIV SeronegativityPreventive Vaccine

Outcome Measures

Primary Outcomes (2)

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

    Week 30

  • Immune response to MRKAd5+6 trigene vaccine

    30 week

Secondary Outcomes (1)

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

    Week 30

Study Arms (8)

1

EXPERIMENTAL

MRKAd6 Trigene 0.5x10\^9 Ad6 vg

Biological: V526

2

EXPERIMENTAL

MRKAd6 Trigene 0.5x10\^10 Ad6 vg

Biological: V526

3

EXPERIMENTAL

MRKAd6 Trigene 0.5x10\^11 Ad6 vg

Biological: V526

4

EXPERIMENTAL

MRKAd5 Trigene 0.5x10\^10 Ad5 vg

Biological: V526

5

EXPERIMENTAL

MRKAd5 Trivalent 1.5x10\^10 Ad5 vg

Biological: V526

6

EXPERIMENTAL

MRKAd5+6 Trigene 1x10\^9 Ad vg

Biological: V526

7

EXPERIMENTAL

MRKAd5+6 Trigene 1x10\^10 Ad vg

Biological: V526

8

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Placebo to V526

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.

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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.

8

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15.

    PMID: 19605598RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

April 1, 2005

Primary Completion

August 1, 2006

Study Completion

March 1, 2011

Last Updated

November 2, 2015

Record last verified: 2015-10