Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster

NCT03553472 | Completed

• 1 other identifier: 2017-0512
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Immune response by T cell, cell mediated immunity, to varicella zoster virus in patients with inflammatory bowel disease.

  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.

  Day 1

Secondary Outcomes (2)

• Immune response by T cells ,cell Mediated Immunity, to varicella zoster virus in Immunosuppressed patients with IBD compared to those non-Immunosuppressed

  Day 1

• Immune response by T cell, cell mediated immunity, to varicella zoster virus in Immunosuppressed IBD patients compared to other immunosuppressed IBD patients

  Day 1

Study Arms (7)

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

Eligibility Criteria

• Age: 35 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

IBD patients with confirmed IBD

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.
• 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.
• 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:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Digestive Health Center

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ELISPOT

MeSH Terms

Conditions

Herpes Zoster; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Freddy Caldera, DO

  University of Wisconsin School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: June 12, 2018
• Study Start: January 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

US (1)