Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00493324
First received: June 27, 2007
Last updated: February 1, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque Psoriasis |
Drug: alefacept Drug: polyvalent pneumococcal vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number and percentage of subjects with an antibody response to pneumococcal antigens [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: alefacept
Intramuscular
Other Names:
Drug: polyvalent pneumococcal vaccine
Injection
Other Name: PNEUMOVAX® 23
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493324
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493324
Locations
| 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, 10029 | |
| New York, New York, United States, 10016 | |
| 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 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00493324 History of Changes |
| Other Study ID Numbers: | 0485-CL-0003 |
| Study First Received: | June 27, 2007 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Astellas Pharma Inc:
|
psoriasis alefacept polyvalent pneumococcal vaccine Immunization |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases Skin Diseases, Papulosquamous Alefacept |
Dermatologic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015