Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal
tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent
epidemiological investigation estimates that nearly 4 million people worldwide are affected
and approximately 1.4 million of these cases occur in the United States. IBD can lead to
debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures
and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic
corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as
tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can
achieve clinical remission and decrease the risk of complications, but also increase the risk
for opportunistic infections, including influenza.
Multiple studies have shown lower influenza vaccine responses in patients with IBD compared
to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF
inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza
serum antibody concentration correlates with protection from infection following vaccination.
Therefore, increasing influenza antibody responses in patients with IBD would appear to be
critical to improving protection from influenza. A high dose (HD) influenza vaccine
containing four times more hemagglutinin was licensed based on its ability to induce higher
antibody concentrations compared to standard dose (SD) in adults 65 years or older.
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