ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02461758
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease (IBD) Biological: Influenza vaccine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Study Start Date : October 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Control Group
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.
Biological: Influenza vaccine
40 patients will be enrolled in the TNF Monotherapy Group 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.

Vedolizumab Group
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
Biological: Influenza vaccine
40 patients will be enrolled in the TNF Monotherapy Group 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.

TNF Monotherapy Group
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) vs. 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.
Biological: Influenza vaccine
40 patients will be enrolled in the TNF Monotherapy Group 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.




Primary Outcome Measures :
  1. Measure antibody concentrations in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine [ Time Frame: 12 month study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 MMR vaccination status
  • Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461758


Locations
United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02461758     History of Changes
Other Study ID Numbers: 2015-0813
Influenza in IBD ( Other Identifier: Study Team )
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vaccines
Vedolizumab
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents