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

November 26, 2018 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tetanus and diphtheria have become rare diseases because of widespread immunization that began during World War II. The percentage of people who got pertussis (whooping cough) also went down after vaccination, but large outbreaks have occurred over the past decade. Measles, mumps, rubella (German measles) and varicella (chicken pox) are illnesses that resolve quickly, but which can cause other diseases to take hold or get worse. Routine vaccination can prevent infection and has been and recommended for use in the United States beginning in the 1960s and 1970s; and in 1995 for varicella. Today measles, mumps, and rubella are especially uncommon in the U.S. thanks to vaccination programs; and the percentage of people with varicella is going down. Despite widespread vaccination efforts, there have been recent outbreaks of measles and mumps in the U.S., in part because these diseases are still common in other parts of the world.

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). Treatment options for IBD consist of immunosuppressive therapy, meaning that the drugs weaken the immune system, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor (vedolizumab). Patients with IBD can achieve clinical remission and decrease the risk of complications with treatment; however, treatment can also increase the risk for infections because they weaken the immune system. Some of these infections are preventable with routine vaccination.

You are invited to take part in this research project to determine if people with IBD on different types of therapy have a lower amount of antibodies than healthy individuals. Antibodies are proteins used by the immune system to attack viruses like tetanus and measles. Antibodies can be introduced into the body through vaccines. The fewer antibodies there are, the harder it is for the antibodies to attack a virus, meaning that the person could get sick with a virus. This research project will help us figure out whether people with IBD have fewer antibodies than people without IBD. The investigators will also look at whether the type of treatment people take for IBD affects the amount of antibodies. T

This will tell us who is more likely to get sick from viruses, and why. The investigators will recruit 90 IBD patients under treatment for their IBD as well as 20 healthy controls for a total of 110 patients at the University of Wisconsin Hospital & Clinics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.
  • 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Case (Group A)
Group A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine (Blood Draw)
Procedure: Blood Draw/Data Collection
Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.
Case (Group B)

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

(Blood Draw)
Procedure: Blood Draw/Data Collection
Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.
Case (Group C)
Group C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate) (Blood Draw)
Procedure: Blood Draw/Data Collection
Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.
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
Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To compare antibody concentrations and seroprotection rates
Time Frame: 12 month study
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
Time Frame: 12 month study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-0340
  • Tetanus/MMR (Other Identifier: UW-Madison Study Staff)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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