Inflammatory Bowel DiseasesPhase 4NCT03798691
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
A Phase 4 study testing Shingrix in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 10 Sep 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between the ages of 18-70 years, inclusive.
- History of primary varicella infection (chicken pox) Confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox
- Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
- Patient has been on stable treatment for IBD for at least three months.
Who cannot join
- Previous receipt of any HZ vaccine
- Allergy to zoster vaccine or a component of it
- Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.)
- History of herpes zoster or post herpetic neuralgia within the past year.
- Patient cannot or will not provide written informed consent.
- Patient is being administered immunomodulators currently or within the past three months
Show all 10Show fewer
- Patient has been taking any dose of oral or intravenous steroids within 30 days prior to immunization.
- Patient has received polyclonal immunoglobulin therapy or blood products within the last year.
- Patient is pregnant per self-reporting or older than age 70 years
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
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: A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.
Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
Read the detailed description
The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy.
The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination.
The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab.
The study population will include adult patients aged 18 to 70 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics. There is no randomization or use of placebo in this study. Two study groups will be established:
- Group A: Patients with IBD on anti-TNF monotherapy
- Group B: Patients with IBD on vedolizumab monotherapy
Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics.
- Being tested
- Shingrix
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixBiological
Also called Recombinant zoster vaccine
Biological: SHINGRIX
SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older.
SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF monotherapy | Active comparator | Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. Receives: Biological: Shingrix |
| Vedolizumab | Active comparator | Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cell Mediated Immunity
The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine.
Measured: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.
Secondary outcomes (6)
Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.
Sustained change in CMI at 6 months will be assessed after receiving a second dose of booster vaccine post-immunization. CMI will be measured via ELISPOT
Measured: Baseline to 6 months post-immunization 2nd dose of vaccine.
Percent of Participants With a Change in Antibody Concentration Post Immunization
A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration.
Measured: pre-immunization to one month 2nd dose post-immunization
Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months
Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed.
Measured: Baseline to 6 months post-immunization
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Measured: Dose 1 (Month 0)
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Measured: Dose 2 (anytime from Month 2 to Month 6)
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
The Simple Clinical Colitis Activity Index (SCCAI) will be used to measure disease activity. It is a questionnaire with six subscore topics with scores defined by UC signs and symptoms from 0 to 4 for a range of scores from 0 to 17. Total scores are interpreted as: Remission = score of 0 to 4 points, Mild Activity = score of 5 to 7 points, Moderate Activity = Score of 8 to 16 points, and Severe Activity = Score of > 16 points. Number of participants experiencing a change will be reported.
Measured: at the baseline visit and one month after receipt of each vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start28 May 2019
- Primary completion12 Oct 2023
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798691
- Sponsor's protocol ID
- 2018-1037
- Other IDs
- SMPH/MEDICINE/GASTROENT, A534250, Protocol Version 11/16/2022
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2019
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caldera F, Mogallapalli H, Abusalim AR, Farraye FA, Hayney MS. Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine in Patients With Inflammatory Bowel Disease on Vedolizumab or Anti-Tumor Necrosis Factor Therapy. Clin Transl Gastroenterol. 2025 Nov 1;16(11):e00924. doi: 10.14309/ctg.0000000000000924.
PubMed 40995992
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
- ClinicalTrials.gov ID
- NCT03798691
- Acronym / sponsor ID
- 2018-1037
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- 28 May 2019 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 2 Apr 2025
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) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.
Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
Detailed description
The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy.
The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination.
The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab.
The study population will include adult patients aged 18 to 70 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics. There is no randomization or use of placebo in this study. Two study groups will be established:
- Group A: Patients with IBD on anti-TNF monotherapy
- Group B: Patients with IBD on vedolizumab monotherapy
Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF monotherapy | Active comparator | Biological: ShingrixPatients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
| Vedolizumab | Active comparator | Biological: ShingrixPatients with IBD on vedolizumab monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is between the ages of 18-70 years, inclusive.
- History of primary varicella infection (chicken pox) Confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox
- Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
- Patient has been on stable treatment for IBD for at least three months.
Key exclusion criteria (10 listed)
- Previous receipt of any HZ vaccine
- Allergy to zoster vaccine or a component of it
- Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.)
- History of herpes zoster or post herpetic neuralgia within the past year.
- Patient cannot or will not provide written informed consent.
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 |
|---|---|---|
| ShingrixAlso: Recombinant zoster vaccineBiological: SHINGRIX SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older. SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. | Biological | Anti-TNF monotherapy, Vedolizumab |
Primary outcome
Change in Cell Mediated Immunity
Time frame: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.
The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine.
6 secondary outcomes
Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.
Time frame: Baseline to 6 months post-immunization 2nd dose of vaccine.
Percent of Participants With a Change in Antibody Concentration Post Immunization
Time frame: pre-immunization to one month 2nd dose post-immunization
Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months
Time frame: Baseline to 6 months post-immunization
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Time frame: Dose 1 (Month 0)
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Time frame: Dose 2 (anytime from Month 2 to Month 6)
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
Time frame: at the baseline visit and one month after receipt of each vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40995992Caldera F, Mogallapalli H, Abusalim AR, Farraye FA, Hayney MS. Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine in Patients With Inflammatory Bowel Disease on Vedolizumab or Anti-Tumor Necrosis Factor Therapy. Clin Transl Gastroenterol. 2025 Nov 1;16(11):e00924. doi: 10.14309/ctg.0000000000000924.
- Individual participant dataSharing planned: No
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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
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shingrix in people with Inflammatory Bowel Diseases and Crohn Disease, 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 5 inclusion and 10 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 2 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cell Mediated Immunity (time frame: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.). 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 NCT03798691, which also lists 1 linked publication.
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 2 Apr 2025.