Herpes ZosterNCT03553472
Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster
An observational study of Herpes Zoster and Inflammatory Bowel Diseases, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Inflammatory Bowel Diseases, Crohn Disease
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 May 2019
- 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 35 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: IBD patients with confirmed IBD
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.
- 3.12 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.
- 3.16 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.
Who cannot join
- 3.21 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Digestive Health Center
Madison, Wisconsin, 53705
About this study
Official title: Identify Young Immunosuppressed and Non-immunosuppressed Inflammatory Bowel Disease Patients at Risk for HZ
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.
Read the detailed description
Inflammatory bowel disease (IBD) is a group of chronic inflammatory disorders of the gastrointestinal tract. A recent national survey from the CDC estimates that the prevalence of IBD in the United States (US) is nearly 3.1 million cases. IBD is often associated with debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options include immunosuppressive therapies, such as corticosteroids, immunomodulators (thiopurines and methotrexate) and anti-tumor necrosis factor alpha (TNF) agents. Although they are effective in achieving clinical remission and decrease the risk of complications, they also increase the risk for serious infections, including herpes zoster (HZ).
The primary goal is to study those patients with IBD who are thought to be at the highest risk for HZ reactivation by evaluating cell mediated immunity (CMI) to VZV.
- Medical subject headings
- Herpes Zoster, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Day 1
Immune response by T cell, cell mediated immunity, to varicella zoster virus in Immunosuppressed IBD patients compared to other immunosuppressed IBD patients
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 .
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Jan 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, Principal investigator, University of Wisconsin School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553472
- Sponsor's protocol ID
- 2017-0512
- Status last verified
- Jun 2019
- First submitted
- 22 Jan 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Young Immunosuppressed and Non-immunosuppressed Inflammatory Bowel Disease Patients at Risk for HZ
- ClinicalTrials.gov ID
- NCT03553472
- Acronym / sponsor ID
- 2017-0512
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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.
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.
Detailed description
Inflammatory bowel disease (IBD) is a group of chronic inflammatory disorders of the gastrointestinal tract. A recent national survey from the CDC estimates that the prevalence of IBD in the United States (US) is nearly 3.1 million cases. IBD is often associated with debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options include immunosuppressive therapies, such as corticosteroids, immunomodulators (thiopurines and methotrexate) and anti-tumor necrosis factor alpha (TNF) agents. Although they are effective in achieving clinical remission and decrease the risk of complications, they also increase the risk for serious infections, including herpes zoster (HZ).
The primary goal is to study those patients with IBD who are thought to be at the highest risk for HZ reactivation by evaluating cell mediated immunity (CMI) to VZV.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IBD patients with confirmed IBD
Key inclusion criteria (3 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.
- 3.12 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.
- 3.16 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.
Key exclusion criteria (1 listed)
- 3.21 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune response by T cell, cell mediated immunity, to varicella zoster virus in patients with inflammatory bowel disease.
Time frame: Day 1
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.
2 secondary outcomes
Immune response by T cells ,cell Mediated Immunity, to varicella zoster virus in Immunosuppressed patients with IBD compared to those non-Immunosuppressed
Time frame: Day 1
Immune response by T cell, cell mediated immunity, to varicella zoster virus in Immunosuppressed IBD patients compared to other immunosuppressed IBD patients
Time frame: Day 1
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 19 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
Freddy Caldera, DO principal investigator
University of Wisconsin School of Medicine
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 Herpes Zoster and Inflammatory Bowel Diseases, 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 3 inclusion and 1 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 19 Jun 2019. 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?
Immune response by T cell, cell mediated immunity, to varicella zoster virus in patients with inflammatory bowel disease. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2019.