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

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ClinicalTrials.gov Identifier: NCT00493324
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: alefacept Drug: polyvalent pneumococcal vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: alefacept
Intramuscular
Other Names:
  • Amevive®
  • ASP0485

Drug: polyvalent pneumococcal vaccine
Injection
Other Name: PNEUMOVAX® 23


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. The number and percentage of subjects with an antibody response to pneumococcal antigens [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493324


Locations
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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
Investigators
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Study Director: Use Central Contact Astellas Pharma US, Inc.
More Information
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Additional Information:
Link to results on JAPIC  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00493324     History of Changes
Other Study ID Numbers: 0485-CL-0003
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Astellas Pharma Inc:
psoriasis
alefacept
polyvalent pneumococcal vaccine
Immunization
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Vaccines
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents