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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: June 27, 2007
Last updated: February 1, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: alefacept
Drug: polyvalent pneumococcal vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The number and percentage of subjects with an antibody response to pneumococcal antigens [ Time Frame: 12 weeks ]

Enrollment: 43
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: alefacept
Other Names:
  • Amevive®
  • ASP0485
Drug: polyvalent pneumococcal vaccine
Other Name: PNEUMOVAX® 23

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00493324

United States, Alabama
Birmingham, Alabama, United States, 35205
United States, California
San Diego, California, United States, 92123
United States, New York
New York, New York, United States, 10016
New York, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44106
Canada, Newfoundland and Labrador
St. John, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
Markham, Ontario, Canada, L3P 1A8
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00493324     History of Changes
Other Study ID Numbers: 0485-CL-0003
Study First Received: June 27, 2007
Last Updated: February 1, 2012

Keywords provided by Astellas Pharma Inc:
polyvalent pneumococcal vaccine

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents processed this record on May 25, 2017