Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829595
• Other study ID #: 6355
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: January 26, 2009
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2009
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females over the age of 18 with inflammatory bowel disease; healthy controls will be age- and sex-matched.

2. The patient must understand and voluntarily sign and informed consent document

3. A history of chronic (greater than 1 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria

4. (Group 1): Outpatients at CSMC IBD center with IBD who are on maintenance anti-TNF therapy with infliximab OR ADALIMUMAB plus concomitant immunomodulator therapy (with either 6MP, AZA, or MTX)

5. (Group 2): Outpatients at CSMC's IBD Center with documented IBD who are not on any immune-suppressive medications. Treatment with oral or topical 5-ASA products, antibiotics, or probiotics, are permitted.

6. (Group 3): Healthy volunteers without chronic illness, not on immune-suppressive medications.

Exclusion Criteria:

1. Hypersensitivity to any component of the vaccine

2. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine (including thyroid), pulmonary, cardiac, infectious, neurologic or cerebral disease. Included are ongoing chronic active conditions such as chronic active hepatitis.

3. Patients who in the judgment of the investigator are unwilling or unable to comply with all the protocol-related assessments and procedures.

4. History of alcohol or other drug abuse within one year, or any conditions associated with poor compliance.

5. Patients in whom venipunctures are not feasible due to poor tolerability or lack of easy access.

6. Healthy volunteers or patients with a history of prior pneumococcal vaccination

7. Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Biological:
• 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)
0.5mL intramuscular, one time

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response, defined by postvaccination antibody titers		1 month	No