Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00493324 |
Recruitment Status :
Completed
First Posted : June 28, 2007
Last Update Posted : February 2, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Plaque Psoriasis | Drug: alefacept Drug: polyvalent pneumococcal vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: alefacept
Intramuscular
Other Names:
Drug: polyvalent pneumococcal vaccine Injection
Other Name: PNEUMOVAX® 23 |
- 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 ]
- The number and percentage of subjects with an antibody response to pneumococcal antigens [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493324
United States, Alabama | |
Birmingham, Alabama, United States, 35205 | |
United States, California | |
San Diego, California, United States, 92123 | |
United States, New York | |
New York, New York, United States, 10016 | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Cleveland, Ohio, United States, 44106 | |
Canada, Newfoundland and Labrador | |
St. John, Newfoundland and Labrador, Canada, A1B 3E1 | |
Canada, Ontario | |
Markham, Ontario, Canada, L3P 1A8 |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Publications:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00493324 |
Other Study ID Numbers: |
0485-CL-0003 |
First Posted: | June 28, 2007 Key Record Dates |
Last Update Posted: | February 2, 2012 |
Last Verified: | January 2012 |
psoriasis alefacept polyvalent pneumococcal vaccine Immunization |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs Dermatologic Agents |