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NCT00493324 Clinical Trial

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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00493324
Other study ID # 0485-CL-0003
Secondary ID
Status Completed
Phase Phase 4
First received June 27, 2007
Last updated February 1, 2012
Start date July 2007
Est. completion date July 2008

Study information
Verified date January 2012
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 43
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• alefacept
Intramuscular
• polyvalent pneumococcal vaccine
Injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers. 12 weeks No
Secondary The number and percentage of subjects with an antibody response to pneumococcal antigens 12 weeks No
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Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
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