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

Inflammatory Bowel Disease (IBD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461758
• Other study ID #: 2015-0813
• Secondary ID: Influenza in IBD
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• Standard dose Influenza vaccine (SDIV)

• High dose influenza vaccine (HDIV)

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Caldera F, Hillman L, Saha S, Wald A, Grimes I, Zhang Y, Sharpe AR, Reichelderfer M, Hayney MS. Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial. Inflamm Bowel — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine	Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.; Higher antibody concentrations are associated with better protection from infection.	Pre-immunization and 2-4 weeks post immunization
Secondary	Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion	Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.	4 weeks
Secondary	Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization	Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals	4 weeks
Secondary	Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization	Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.	4 weeks
Secondary	Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine	Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.; Higher antibody concentrations are associated with better protection from infection.	6 months post-immunization