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

Astellas

Status and phase: Completed; Phase 4

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: alefacept; Drug: polyvalent pneumococcal vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493324

0485-CL-0003

Details and patient eligibility

About

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.

Full description

This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

1

Experimental group

Treatment:

Drug: polyvalent pneumococcal vaccine

Drug: alefacept