Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Inflammatory Bowel Disease (IBD)
About this trial
This is an interventional prevention trial for Inflammatory Bowel Disease (IBD)
Eligibility Criteria
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 Measles, Mumps, and Rubella (MMR) vaccination status
- Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
Sites / Locations
- University of Wisconsin Hospital & Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Control Group
Vedolizumab Group + standard dose influenza vaccine (SDIV)
High dose influenza vaccine (HDIV)
Standard dose influenza vaccine (SDIV)
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.