Skip to main content
OpenTrials
Completed

NCT Number: NCT00493324

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. John's, Newfoundland and Labrador, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alefacept

Drug

Intramuscular

Other names: Amevive®, ASP0485

polyvalent pneumococcal vaccine

Drug

Injection

Other names: PNEUMOVAX® 23

Primary outcomes

  1. 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

  1. The number and percentage of subjects with an antibody response to pneumococcal antigens

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 28, 2007
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.