Back to results

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

About this trial

This is an interventional prevention trial for Inflammatory Bowel Disease focused on measuring inflammatory bowel disease, Crohn disease, ulcerative colitis, immunosuppression, anti tumor necrosis alpha, pneumovax, pneumococcal vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males and females over the age of 18 with inflammatory bowel disease; healthy controls will be age- and sex-matched.
The patient must understand and voluntarily sign and informed consent document
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
(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)
(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.
(Group 3): Healthy volunteers without chronic illness, not on immune-suppressive medications.

Exclusion Criteria:

Hypersensitivity to any component of the vaccine
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.
Patients who in the judgment of the investigator are unwilling or unable to comply with all the protocol-related assessments and procedures.
History of alcohol or other drug abuse within one year, or any conditions associated with poor compliance.
Patients in whom venipunctures are not feasible due to poor tolerability or lack of easy access.
Healthy volunteers or patients with a history of prior pneumococcal vaccination
Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

IBD, on both an anti-TNF agent and an immunomodulator

IBD, not on any immunosuppressive medications

Healthy, non-IBD, not on immunosuppressive medications (control arm)

Outcomes

Primary Outcome Measures

Response, defined by postvaccination antibody titers

Secondary Outcome Measures

Full Information

NCT ID

NCT00829595

First Posted

January 23, 2009

Last Updated

January 26, 2009

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00829595

Brief Title

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Official Title

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis

Keywords

inflammatory bowel disease, Crohn disease, ulcerative colitis, immunosuppression, anti tumor necrosis alpha, pneumovax, pneumococcal vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

IBD, on both an anti-TNF agent and an immunomodulator

Arm Title

Arm Type

Experimental

Arm Description

IBD, not on any immunosuppressive medications

Arm Title

Arm Type

Active Comparator

Arm Description

Healthy, non-IBD, not on immunosuppressive medications (control arm)

Intervention Type

Biological

Intervention Name(s)

23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

Other Intervention Name(s)

Pneumovax

Intervention Description

0.5mL intramuscular, one time

Primary Outcome Measure Information:

Title

Response, defined by postvaccination antibody titers

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females over the age of 18 with inflammatory bowel disease; healthy controls will be age- and sex-matched. The patient must understand and voluntarily sign and informed consent document 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 (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) (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. (Group 3): Healthy volunteers without chronic illness, not on immune-suppressive medications. Exclusion Criteria: Hypersensitivity to any component of the vaccine 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. Patients who in the judgment of the investigator are unwilling or unable to comply with all the protocol-related assessments and procedures. History of alcohol or other drug abuse within one year, or any conditions associated with poor compliance. Patients in whom venipunctures are not feasible due to poor tolerability or lack of easy access. Healthy volunteers or patients with a history of prior pneumococcal vaccination Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric A Vasiliauskas, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

We'll reach out to this number within 24 hrs