Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis

February 1, 2012 updated by: Astellas Pharma Inc

An Open-Label Phase 4 Study in Adult Patients With Chronic Plaque Psoriasis to Evaluate the Immune Response to Pneumococcal Vaccine in Subjects Treated With Alefacept

A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John, Newfoundland and Labrador, Canada, A1B 3E1
    • Ontario
      • Markham, Ontario, Canada, L3P 1A8
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • California
      • San Diego, California, United States, 92123
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
    • Ohio
      • Cleveland, Ohio, United States, 44106

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has chronic plaque psoriasis
  • Subject has at least 5% body surface area affected with psoriasis

Exclusion Criteria:

  • Skin disorder other than plaque psoriasis in affected area
  • Previously immunized with any pneumococcal vaccine
  • Subject has pustular or erythrodermic psoriasis
  • Subject is immunocompromised
  • Six or more herpes simplex virus outbreaks per year
  • History or malignancy, chronic serious infection or hepatic disease

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: alefacept
Intramuscular
Other Names:
  • ASP0485
  • Amevive®
Drug: polyvalent pneumococcal vaccine
Injection
Other Names:
  • PNEUMOVAX® 23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of subjects with an antibody response to pneumococcal antigens
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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

Helpful Links

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

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0485-CL-0003

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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