Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine

Completed

Conditions studied: Inflammatory Bowel Disease (IBD), Immunosuppressed or Non-Immunosuppressed, Influenza Vaccine, Antibody Titers, Seroprotective Titers

In brief

The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.

Key facts

Study ID: NCT00542776
Run by: Boston Children's Hospital
People needed: 146
Starts: 2007-10-01
Expected to finish: 2008-02-01
Last updated by the study team: 2008-05-01

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria.
Age 5 years and older
Actively or previously followed by a gastroenterologist at Children's Hospital Boston
On non-immunosuppressants (aminosalicylates, antibiotics, or no medications) and/or immunosuppressants (steroids, immunomodulators, TNF-alpha inhibitors) for the past 30 days. Standard concomitant medications (e.g. antihistamines, acetaminophen) will be allowed.

You may not qualify if…

History of bleeding disorder that would make hematoma likely (eg hemophilia, von Willebrand's disease)
Received influenza vaccination during the current influenza season
Contraindications to the influenza vaccine (such as severe allergic reaction to prior influenza vaccine)
Fever within 48 hr prior to injection
Receipt of another vaccination within 2 days of influenza vaccine dose (and no other vaccines planned for 2 days after influenza vaccine)

Where it is running

Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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