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

NCT02434133 | Completed

• 2 other identifiers: 2015-0340Tetanus/MMR
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (2)

• To compare antibody concentrations and seroprotection rates

  To compare tetanus, diphtheria, and pertussis antibody concentrations and seroprotection rates in patients with IBD treated with combination therapy to healthy individuals.

  12 month study

• To compare antibody concentrations and seroprotection rates

  To compare measles, mumps, and rubella antibody concentrations and seroprotection rates in patients with IBD treated with combination therapy to healthy individuals.

  12 month study

Study Arms (4)

Case (Group A)

Group A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine (Blood Draw)

Procedure: Blood Draw/Data Collection

Case (Group B)

Group B (Biologic group) currently taking anti-TNF therapy (infliximab, golimumab, adalimumab, or certolizumab). (Blood Draw)

Procedure: Blood Draw/Data Collection

Case (Group C)

Group C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate) (Blood Draw)

Procedure: Blood Draw/Data Collection

Control

Individuals will be obtained from patients without an IBD diagnosis coming to Digestive Health Center for endoscopic procedures or clinic visits. (Blood Draw)

Procedure: Blood Draw/Data Collection

Interventions

Blood Draw/Data Collection PROCEDURE

Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.

Case (Group A); Case (Group B); Case (Group C); Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of individuals with inflammatory bowel disease and healthy controls.

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.
• 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.
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Caldera F, Misch EA, Saha S, Wald A, Zhang Y, Hubers J, Megna B, Ley D, Reichelderfer M, Hayney MS. Immunosuppression Does Not Affect Antibody Concentrations to Measles, Mumps, and Rubella in Patients with Inflammatory Bowel Disease. Dig Dis Sci. 2019 Jan;64(1):189-195. doi: 10.1007/s10620-018-5321-z. Epub 2018 Oct 13.

  PMID: 30317494 DERIVED

• Caldera F, Saha S, Wald A, Garmoe CA, McCrone S, Megna B, Ley D, Reichelderfer M, Hayney MS. Lower Sustained Diphtheria and Pertussis Antibody Concentrations in Inflammatory Bowel Disease Patients. Dig Dis Sci. 2018 Jun;63(6):1532-1540. doi: 10.1007/s10620-018-5043-2. Epub 2018 Mar 29.

  PMID: 29594970 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample to measure antibody concentration

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

US (1)