Back to resultsStudy to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
alefacept
polyvalent pneumococcal vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Plaque Psoriasis focused on measuring psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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.
Secondary Outcome Measures
The number and percentage of subjects with an antibody response to pneumococcal antigens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00493324
Brief Title
Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
alefacept
Other Intervention Name(s)
Amevive®, ASP0485
Intervention Description
Intramuscular
Intervention Type
Drug
Intervention Name(s)
polyvalent pneumococcal vaccine
Other Intervention Name(s)
PNEUMOVAX® 23
Intervention Description
Injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The number and percentage of subjects with an antibody response to pneumococcal antigens
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
St. John
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21453987
Citation
Lynde C, Krell J, Korman N, Mathes B; Vaccine Study Investigators. Immune response to pneumococcal polysaccharide vaccine in adults with chronic plaque psoriasis treated with alefacept. J Am Acad Dermatol. 2011 Oct;65(4):799-806. doi: 10.1016/j.jaad.2010.04.040. Epub 2011 Mar 30.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=336
Description
Link to results on JAPIC
Learn more about this trial
Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
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