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NCT00829595 · ClinicalTrials.gov registry record · NA
Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease
A NA study of Ulcerative Colitis and Crohn Disease, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT00829595 is a NA study of Ulcerative Colitis and Crohn Disease that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 69 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00829595, a NA study of Ulcerative Colitis and Crohn Disease, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- BIOLOGICAL 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2005-05 |
| Est. Completion | 2007-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00829595
The ClinicalTrials.gov registry entry for NCT00829595 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) is the first listed.
NCT00829595 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00829595 about?
NCT00829595 is a clinical study titled "Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease". 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 t...
What is the current status of trial NCT00829595?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2005-05. Estimated completion is 2007-12.
What conditions does trial NCT00829595 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Disease.
What interventions are being tested in trial NCT00829595?
The interventions under investigation include: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00829595?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00829595 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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