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Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster

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ClinicalTrials.gov Identifier: NCT03553472
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
Inflammatory bowel disease (IBD) patients under the age of 50 can have a greater risk than the general population above age 50. IBD patient are commonly treated with immunosuppression that increases the risk for Herpes Zoster. A new HZ vaccine is available that could decrease the risk of HZ in IBD patients.

Condition or disease
Herpes Zoster Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Detailed Description:

Inflammatory bowel disease (IBD) is a group of chronic inflammatory disorders of the gastrointestinal tract. A recent national survey from the CDC estimates that the prevalence of IBD in the United States (US) is nearly 3.1 million cases. IBD is often associated with debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options include immunosuppressive therapies, such as corticosteroids, immunomodulators (thiopurines and methotrexate) and anti-tumor necrosis factor alpha (TNF) agents. Although they are effective in achieving clinical remission and decrease the risk of complications, they also increase the risk for serious infections, including herpes zoster (HZ).

The primary goal is to study those patients with IBD who are thought to be at the highest risk for HZ reactivation by evaluating cell mediated immunity (CMI) to VZV.


Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Identify Young Immunosuppressed and Non-immunosuppressed Inflammatory Bowel Disease Patients at Risk for HZ
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort
Non-immunosuppressed IBD patients
24 IBD patients on mesalamine therapy or no IBD therapy
Thiopurine group
12 IBD patients on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
Anti-TNF therapy
12 IBD patients on maintenance therapy infliximab (at least 8 every 8 weeks), golilumab (at least monthly), adalilumab (at least every 2 weeks), or certolizumab (at least monthly)
Combination therapy
12 IBD patients on anti-TNF therapy as described in group along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
Healthy Control

The control group with consist of 12 individuals who meet the following inclusion and exclusion criteria.

Individuals will be obtained from patients without an IBD diagnosis, chronic liver disease, celiac disease or other chronic health condition coming to Digestive Health Center for endoscopic procedures or clinic visits.

Vedolizumab therarpy
12 IBD patients on vedolizumab maintenance therapy every 4-8 weeks
Prednisone and Anti-TNF therapy
12 IBD patients on Anti-TNF maintenance therapy as combination or mono therapy along with at least 10mg of prednisone



Primary Outcome Measures :
  1. Immune response by T cell, cell mediated immunity, to varicella zoster virus in patients with inflammatory bowel disease. [ Time Frame: Day 1 ]
    ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella cell mediated immunity.


Secondary Outcome Measures :
  1. Immune response by T cells ,cell Mediated Immunity, to varicella zoster virus in Immunosuppressed patients with IBD compared to those non-Immunosuppressed [ Time Frame: Day 1 ]
    ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella cell mediated immunity.

  2. Immune response by T cell, cell mediated immunity, to varicella zoster virus in Immunosuppressed IBD patients compared to other immunosuppressed IBD patients [ Time Frame: Day 1 ]
    ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella .


Biospecimen Retention:   Samples Without DNA
ELISPOT


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Ages Eligible for Study:   35 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
IBD patients with confirmed IBD
Criteria

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.

3.12 Ages 40-55 3.13 There will four groups divided by medication group. All patients will be on stable doses of medication for at least 3 months divided in the following groups: A) Group A (24 patients): mesalamine therapy or no IBD therapy B) Group B (12 patients): Thiopurine group: On azathiopurine at least 2.0mg/kg or 6MP 1.0mg/kg C) Group C (12 patients): Anti-TNF therapy group: On maintenance therapy infliximab (at least 8 every 8 weeks), golilumab (at least monthly), adalilumab (at least every 2 weeks), or certolizumab (at least monthly) D) Group D (12 patients): Combination therapy: On anti-TNF therapy as described in group along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg 3.14 Previous history of varicella infection verified by positive VZV IgG test. 3.15 The patient must understand and voluntarily sign the informed consent document.

3.16 All participants must have received a tetanus, diphtheria, pertussis (Tdap) or tetanus, diphtheria (Td) within the previous 10 years the Wisconsin Immunization Registry (WIR), will be accessed via the EMR, so confirming immunization will not be a limitation) because tetanus CMI will be used as an experimental control.

Exclusion Criteria:

3.21 Current use of systemic steroids 3.22 Other autoimmune condition (e.g Rheumatoid arthritis, autoimmune hepatitis) 3.23 Receipt of HZ vaccine (As above, via WIR) 3.24 History of cytopenia in the last 12 months (WBC < 3.0 or anemia Hgb <10). (All patients on immunosuppressants routinely obtain blood work every 3-6 months, so this will be available at study entry) 3.25 History of previous herpes zoster infection.


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): NCT03553472


Contacts
Contact: Lindsey Luedke 608-263-4185 luedke@medicine.wisc.edu
Contact: Freddy Caldera, DO 608-263-4185 fcaldera@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Digestive Health Center Recruiting
Madison, Wisconsin, United States, 53705
Contact: Lindsey Leudke       leluedke@medicine.wisc.edu   
Contact: Freddy Caldera       fcaldera@medicine.wisc.edu   
Principal Investigator: Freddy Caldera, DO         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Freddy Caldera, DO University of Wisconsin School of Medicine

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03553472     History of Changes
Other Study ID Numbers: 2017-0512
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Herpes Zoster
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vedolizumab
Gastrointestinal Agents