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Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

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Contents

clinicaltrials.gov/study/NCT00829595
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT008295950
Health Conditions in Trial
Ulcerative colitis
Ulcerative colitis
0
Inflammatory bowel disease
Inflammatory bowel disease
0
Trial Recruitment Size
690
Trial Sponsor
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
0
Clinical Trial Start Date
2005
0
Primary Completion Date
2007
0
Study Completion Date
2007
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Biological0
Interventional Trial Phase
Not Applicable0
Participating Facility
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
0
Official Name
Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease0
Last Updated
January 27, 2009
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)0
Study summary

Patients with inflammatory bowel disease (IBD) will be assessed for immunologic response to pneumococcal vaccination. Patients with IBD meet criteria as outlined by the Centers for Disease Control (CDC) for pneumococcal vaccination, yet the investigators have found that pneumococcal vaccination in this population is under-utilized. It is unknown whether or not IBD or IBD-related medications impact the immune response to this recommended vaccine. Three groups of 25 patients each will be recruited. The first group will consist of outpatients with IBD who are receiving infliximab (Remicade TM) while on concommitant immunosuppressive therapy (with either 6MP, azathioprine, or methotrexate). This group is intended to represent a common 'heavily immunosuppressed' patient group with IBD. The second group will consist of patients with IBD seen in our outpatient clinic who are not on any immune-suppressive medications. These patients meet CDC criteria for vaccination by virtue of having a chronic medical illness. The third group will consist of healthy age-matched (to the first group) controls. After obtaining informed consent, patients will be screened with baseline lab tests including testing for antibodies against pneumococcus. At the baseline visit, patients will also undergo a brief medical history, physical examination, and assessment of their IBD disease activity. Included patients will then undergo a one-time intramuscular vaccination with 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM). One month later, subjects will return for a blood draw to assess for response to pneumococcal vaccination.

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