Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster

Completed

Conditions studied: Herpes Zoster, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT03553472

Run by

University of Wisconsin, Madison

People needed

97

Starts

2018-01-01

Expected to finish

2019-05-31

Last updated by the study team

2019-06-19

Who can join

Age: 35 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• University of Wisconsin Digestive Health Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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