Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Inflammatory Bowel Disease (IBD)

Treatments: Biological: High dose influenza vaccine (HDIV); Biological: Standard dose Influenza vaccine (SDIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT02461758

2015-0813

Influenza in IBD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 4 patient groups

Control Group

Other group

Description:

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.

Treatment:

Biological: Standard dose Influenza vaccine (SDIV)

Vedolizumab Group + standard dose influenza vaccine (SDIV)

Other group

Description:

A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV

Treatment:

Biological: Standard dose Influenza vaccine (SDIV)

High dose influenza vaccine (HDIV)

Other group

Description:

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.

Treatment:

Biological: High dose influenza vaccine (HDIV)

Standard dose influenza vaccine (SDIV)

Other group

Description:

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.

Treatment:

Biological: Standard dose Influenza vaccine (SDIV)