Inflammatory Bowel Disease (IBD)NCT02434133
Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients
An observational study of Inflammatory Bowel Disease (IBD), run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Blood Draw/Data Collection
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population will consist of individuals with inflammatory bowel disease and healthy controls.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Blood Draw/Data Collection
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Draw/Data CollectionProcedure or surgery
Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.
| Study group | Role | What they receive |
|---|---|---|
| Case (Group A) | Group A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine (Blood Draw) Receives: Procedure: Blood Draw/Data Collection | |
| Case (Group B) | Group B (Biologic group) currently taking anti-TNF therapy (infliximab, golimumab, adalimumab, or certolizumab).
(Blood Draw) Receives: Procedure: Blood Draw/Data Collection | |
| Case (Group C) | Group C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate) (Blood Draw) Receives: 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) Receives: Procedure: Blood Draw/Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434133
- Sponsor's protocol ID
- 2015-0340
- Other IDs
- Tetanus/MMR
- Status last verified
- Nov 2018
- First submitted
- 27 Apr 2015
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30317494Caldera 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.
PubMed 29594970
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT02434133
- Acronym / sponsor ID
- 2015-0340
- Conditions
- Inflammatory Bowel Disease (IBD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Case (Group A) | – | Procedure: Blood Draw/Data CollectionGroup A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine (Blood Draw) |
| Case (Group B) | – | Procedure: Blood Draw/Data CollectionGroup B (Biologic group) currently taking anti-TNF therapy (infliximab, golimumab, adalimumab, or certolizumab). (Blood Draw) |
| Case (Group C) | – | Procedure: Blood Draw/Data CollectionGroup C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate) (Blood Draw) |
| Control | – | Procedure: Blood Draw/Data CollectionIndividuals will be obtained from patients without an IBD diagnosis coming to Digestive Health Center for endoscopic procedures or clinic visits. (Blood Draw) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of individuals with inflammatory bowel disease and healthy controls.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw/Data CollectionParticipation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history. | Procedure or surgery | Case (Group A), Case (Group B), Case (Group C), Control |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 30317494Caldera 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.
- Derived from this study: PubMed 29594970Caldera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare antibody concentrations and seroprotection rates (time frame: 12 month study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434133, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.