Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 11/29/2018 |
| Start Date: | October 2016 |
| End Date: | July 2018 |
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.
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.
CASES Specific Aim #1 Inclusion Criteria
- A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease
diagnosed and documented by the standard clinical, radiographic, endoscopic and
histopathologic criteria.
- Ages 18-64
- Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab)
for at least 3 months
- Exclusion Criteria
- Received season's influenza vaccine
- Allergy to eggs or influenza vaccine
- Currently use of systemic steroids in the past 3 months
Specific Aim #2 Inclusion criteria
- A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease
diagnosed and documented by the standard clinical, radiographic, endoscopic and
histopathologic criteria.
- Ages 18-64
- Currently on vedolizumab therapy
Exclusion Criteria
- Received season's influenza vaccine
- Allergy to eggs or influenza vaccine
- Currently use of systemic steroids in the past 3 months
Control group Inclusion criteria
- Age 18-64
- Willing to participate in study
Control group Exclusion criteria
- Currently on immunosuppressive therapy
- Has a chronic health condition that may have an impact on vaccine antibody
concentrations as deemed by the investigators, including chronic liver disease, celiac
disease, history of solid organ or bone marrow transplantation.
- Older than age 65 years
- Unconfirmed MMR vaccination status
- Patients in whom venipuncture are not feasible due to poor tolerability or lack of
easy access.
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-263-4185
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