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| Sponsor: | Cedars-Sinai Medical Center |
|---|---|
| Information provided by: | Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00829595 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis |
Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease |
| Enrollment: | 69 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
IBD, on both an anti-TNF agent and an immunomodulator
|
Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)
0.5mL intramuscular, one time
Other Name: Pneumovax
|
|
Experimental: 2
IBD, not on any immunosuppressive medications
|
Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)
0.5mL intramuscular, one time
Other Name: Pneumovax
|
|
Active Comparator: 3
Healthy, non-IBD, not on immunosuppressive medications (control arm)
|
Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)
0.5mL intramuscular, one time
Other Name: Pneumovax
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: | Eric A Vasiliauskas, MD | Cedars-Sinai Medical Center |
More Information
| Responsible Party: | Gil Melmed, MD, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00829595 History of Changes |
| Other Study ID Numbers: | 6355 |
| Study First Received: | January 23, 2009 |
| Last Updated: | January 26, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
inflammatory bowel disease Crohn disease ulcerative colitis immunosuppression |
anti tumor necrosis alpha pneumovax pneumococcal vaccine |
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |