Skip to main content
OpenTrials
Completed

NCT Number: NCT02461758

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Disease (IBD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard dose Influenza vaccine (SDIV)

Biological

High dose influenza vaccine (HDIV)

Biological

Primary outcomes

  1. Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine

    Time frame: Pre-immunization and 2-4 weeks post immunization

    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.

Secondary outcomes

  1. Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion

    Time frame: 4 weeks

    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.

  2. Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization

    Time frame: 4 weeks

    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

  3. Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization

    Time frame: 4 weeks

    Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.

  4. Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine

    Time frame: 6 months post-immunization

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 3, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.