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

NCT ID: NCT00493324

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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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

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

Conditions

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Chronic Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

alefacept

Intervention Type DRUG

Intramuscular

polyvalent pneumococcal vaccine

Intervention Type DRUG

Injection

Interventions

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alefacept

Intramuscular

Intervention Type DRUG

polyvalent pneumococcal vaccine

Injection

Intervention Type DRUG

Other Intervention Names

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Amevive® ASP0485 PNEUMOVAX® 23

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

San Diego, California, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

St. John's, Newfoundland and Labrador, Canada

Site Status

Markham, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 21453987 (View on PubMed)

Other Identifiers

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0485-CL-0003

Identifier Type: -

Identifier Source: org_study_id

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