Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients

Completed

Conditions studied: Inflammatory Bowel Disease (IBD)

In brief

The investigators proposed study is the first of its kind. The investigators will measure measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the current IBD treatment modalities and compare the vaccine antibody concentrations and correlate them with time since immunization.

Key facts

Study ID

NCT02434133

Run by

University of Wisconsin, Madison

People needed

110

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older, up to 65. 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.
• Undergoing blood work the day of the study visit for routine blood monitoring due to medication.
• Has a documented tetanus-diphtheria (Td) or tetanus-diphtheria-acellular pertussis (Tdap) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
• Has a document measles, mumps and rubella (MMR) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study. This will need to be met by 50% of patient in group A-C.
• Is currently taking one of the following medication regimens for at least 3 months.
• Group A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine
• Group B (Biologic group) currently taking anti-TNF therapy (infliximab, golimumab, adalimumab, or certolizumab).
• Group C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate)
• The patient must understand and voluntarily sign the informed consent document.

You may not qualify if…

• Unconfirmed Td or Tdap vaccination status
• Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
• CONTROLS Inclusion Criteria
• Has a documented tetanus-diphtheria (Td) or tetanus-diphtheria-acellular pertussis (Tdap) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
• Has a document measles, mumps and rubella (MMR) at least two injections in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
• CONTROLS 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.

Where it is running

• University of Wisconsin Hospital & Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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