Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
Phase 4
Completed
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Drug: polyvalent pneumococcal vaccine
- Registration Number
- NCT00493324
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 alefacept - 1 polyvalent pneumococcal vaccine -
- Primary Outcome Measures
Name Time Method The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers. 12 weeks
- Secondary Outcome Measures
Name Time Method The number and percentage of subjects with an antibody response to pneumococcal antigens 12 weeks