Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Standard dose Influenza vaccine (SDIV); High dose influenza vaccine (HDIV)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

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.