NCT00493324CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 43
- Primary Endpoint
- The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
Intervention: alefacept (Drug)
1
Experimental
Intervention: polyvalent pneumococcal vaccine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- The number and percentage of subjects with an antibody response to pneumococcal antigens(12 weeks)
Investigators
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