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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00493324

Enrollment

Registered

2007-06-28

Start date

2007-07-31

Completion date

2008-07-31

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization

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.

Interventions

DRUGalefacept

Intramuscular

DRUGpolyvalent pneumococcal vaccine

Injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The number and percentage of subjects with an antibody response to pneumococcal antigens	12 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026