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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
Results First Posted : September 13, 2019
Last Update Posted : October 2, 2019
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: Standard dose Influenza vaccine (SDIV) Biological: High dose influenza vaccine (HDIV) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 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: Standard dose Influenza vaccine (SDIV)
Vedolizumab Group + standard dose influenza vaccine (SDIV)
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
Biological: Standard dose Influenza vaccine (SDIV)
High dose influenza vaccine (HDIV)

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.

Biological: High dose influenza vaccine (HDIV)
Standard dose influenza vaccine (SDIV)

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.

Biological: Standard dose Influenza vaccine (SDIV)



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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.


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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 Measles, Mumps, and Rubella (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
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United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Freddy Caldera University of Wisconsin School of Medicine and Public Health, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Study Protocol  [PDF] January 27, 2017
Statistical Analysis Plan  [PDF] August 13, 2015

Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02461758    
Other Study ID Numbers: 2015-0813
Influenza in IBD ( Other Identifier: Study Team )
First Posted: June 3, 2015    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vaccines
Immunologic Factors
Physiological Effects of Drugs