Ulcerative Colitis Clinical Trial
Official title:
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 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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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