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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00493324
First received: June 27, 2007
Last updated: February 1, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and percentage of subjects with an antibody response to pneumococcal antigens [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Intramuscular
Other Names:
  • Amevive®
  • ASP0485
Drug: polyvalent pneumococcal vaccine
Injection
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00493324

Locations
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, 10029
New York, New York, United States, 10016
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
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00493324     History of Changes
Other Study ID Numbers: 0485-CL-0003
Study First Received: June 27, 2007
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
psoriasis
alefacept
polyvalent pneumococcal vaccine
Immunization

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014