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Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease


N/A
18 Years
N/A
Not Enrolling
Both
Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis

Thank you

Trial Information

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response, defined by postvaccination antibody titers

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Eric A Vasiliauskas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Institutional Review Board

Study ID:

6355

NCT ID:

NCT00829595

Start Date:

May 2005

Completion Date:

December 2007

Related Keywords:

  • Inflammatory Bowel Disease
  • Crohn Disease
  • Ulcerative Colitis
  • 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

Name

Location

Cedars-Sinai Medical CenterLos Angeles, California  90048