CClinicalTrials.gg
Sign In
CompletedNCT00829595Updated Jan 27, 2009

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

An interventional study of 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) in Inflammatory Bowel Disease, Crohn Disease and Ulcerative Colitis, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-27.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Inflammatory Bowel Disease
  • Crohn Disease
  • Ulcerative Colitis

Keywords

  • inflammatory bowel disease
  • Crohn disease
  • ulcerative colitis
  • immunosuppression
  • anti tumor necrosis alpha
  • pneumovax
  • pneumococcal vaccine
03

In context

Colitis

1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.

This study's enrollment of 69 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    1

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

    Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

  • Experimental
    2

    IBD, not on any immunosuppressive medications

    Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

  • Active comparator
    3

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

    Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

Interventions

  • Biological23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

    0.5mL intramuscular, one time

    Also known as: Pneumovax

06

What researchers measure

Primary outcomes

  1. Response, defined by postvaccination antibody titers

    Time frame: 1 month

07

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829595
Lead sponsor
Cedars-Sinai Medical Center
First posted
Jan 27, 2009
Start date
May 2005
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jan 27, 2009

Study contacts

Eric A Vasiliauskas, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colitis→

Other studies from this sponsor

Cedars-Sinai Medical Center

Start the discussion