Inflammatory Bowel DiseasesPhase 4NCT06224270
Study of Response to Zoster Vaccine in Adults with Inflammatory Bowel Disease Treated with Medications
A Phase 4 study testing Adjuvanted Recombinant Zoster Vaccine (RZV) in people with Inflammatory Bowel Diseases and IBD, run by University of Wisconsin, Madison at 6 sites in United States.
Trial summary
This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases, IBD
- What is being tested?
- Adjuvanted Recombinant Zoster Vaccine (RZV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2024to Sep 2027
- Phase
- Phase 4
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria.
- Can provide appropriate written informed consent.
- Patient has a history of ulcerative colitis or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- Patient is receiving one of the following treatments for their IBD:
- Anti-TNF therapy (infliximab, adalimumab, certolizumab, or golimumab)
- On anti-TNF monotherapy
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- Or anti-TNF therapy in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6-Mercaptopurine (6MP) 0.5mg/kg
- Non-TNF therapy
- On ustekinumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- On vedolizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- On Risankizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- On mirikizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- Janus Kinase Inhibitor
- On tofacitinib at least 5mg PO twice per day (BID)
- On upadactinib at least 15mg PO BID
- Patient has been on stable biologic or JAK treatment for IBD for at least two months.
- Patient is in stable clinical remission
- o No recent corticosteroid prescription within the past two months.
- Female participant of non-childbearing potential (pre-menarche, current tubal ligation, hysterectomy, oophorectomy or post-menopause) and childbearing potential (if they had: practiced adequate contraception (include IUD or equivalent, hormonal contraceptive (e.g. pill, patch, ring, implant or an injection used consistently and that has reached full effect prior to the first dose of vaccine), hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy) for 1 month prior to vaccination and agrees to continue adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series). Non-pregnant females with a negative pregnancy test who are willing to practice adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series).
Who cannot join
- Patient cannot or will not provide written informed consent.
- Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization.
- Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
- Previous vaccination against HZ or varicella within the 12M preceding the first dose of RZV.
- Occurrence of varicella or HZ per clinical history, within the 12M preceding the first dose of RZV.
- Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to the use of induction and/or maintenance immunosuppressive therapies.
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- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
- Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
- Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e. 2 months after last dose of study V2).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mercy Medical Center
Baltimore, Maryland, 21202
University of North Carolina
Chapel Hill, North Carolina, 27599
Mayo Clinic
Jacksonville, Florida, 32224
UW Hospital and Clinics
Madison, Wisconsin, 53792
Vanderbilt University
Nashville, Tennessee, 37235
New York University
New York, New York, 10012
About this study
Official title: Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adults with Inflammatory Bowel Disease on Biologic Immunosuppressive Therapies
This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.
Read the detailed description
Study Visits:
- Visit 1 (V1) - day 1 - blood draw, RZV dose 1
- Follow up (FU) 1 - between days 7-15
- FU 2 - between days 22-29
- Visit 2 (V2) - between days 30-90 - RZV dose 2
- FU 3 - V2 + 7-14 days
- Visit 3 (V3) - V2 + 21-50 days - blood draw
- Visit 4 (V4) - V2 + approximately 360 days - blood draw
Primary Objective:
- To demonstrate a 10% higher humoral immunogenicity following two doses of RZV in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Secondary Objectives:
- To evaluate the vaccine response rate (VRR) for anti-glycoprotein E (gE) humoral immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To characterize the anti-gE humoral immunogenicity at visit 1 (V1), visit 3 (V3), and visit 4 (V4) in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To evaluate the safety and reactogenicity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period.
- To evaluate IBD activity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period.
Tertiary/Exploratory Objectives:
- To characterize gE-specific CD4+ T-cell mediated immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To characterize gE-specific CD4+ T-cell mediated immune responses in patients on JAKs.
- To evaluate the VRR for anti-gE humoral immune responses in patients on Janus Kinase inhibitors (JAKs).
- To characterize the anti-gE humoral immunogenicity at V1, V3, and V4 in patients on JAKs.
- To determine the relationship between gut microbiota and response to RZV series.
- Conditions
- Inflammatory Bowel Diseases, IBD
- Being tested
- Adjuvanted Recombinant Zoster Vaccine (RZV)
- Keywords
- immunosuppressed, Recombinant Zoster Vaccine
- 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.
Adjuvanted Recombinant Zoster Vaccine (RZV)Biological
The RZV vaccine is indicated for prevention of herpes zoster (HZ) in adults aged 18 years and older who are or will be at increased risk of HZ. Patients with IBD on immunosuppressive therapy are at increased risk for HZ.
| Study group | Role | What they receive |
|---|---|---|
| Adults with IBD | Experimental | Not described Receives: Biological: Adjuvanted Recombinant Zoster Vaccine (RZV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentrations of Anti-gE Antibodies
Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) at V3, following 2 doses of RZV, in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Measured: Visit 3 (between 50 and 140 days on study)
Secondary outcomes (10)
Vaccine response rate (VRR)
Vaccine response rate (VRR) with exact 95% confidence intervals at V3 in those on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Measured: Visit 3 (between 50 and 140 days on study)
Seropositivity rate
Seropositivity rate with exact 95% confidence interval (CI) at V1, V3, and V4 in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Measured: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Geometric Mean Concentrations of Anti-gE Antibodies
Anti-gE antibody concentrations expressed as GMC with 95% CI at V1, V3, and V4 in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Measured: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Number of Participants with Solicited Adverse Events (AEs)
Number and percentage of patients reporting each solicited local AE and each solicited systemic AE within 7 days (Days 1-7) after each dose and overall for all study groups.
Solicited local AEs are: injection site pain, redness, swelling.
Solicited systemic AEs are: fatigue, myalgia, arthralgia, headache, shivering/chills, fever and gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain).
Measured: Up to 7 days after Visit 1, up to 7 days after Visit 2
Number of Participants with Unsolicited Adverse Events
Number and percentage of patients reporting unsolicited AEs within 30 days (Days 1-30) after each dose and overall, for all study groups.
Measured: up to 30 days after Visit 1, up to 30 days after Visit 2
Number of Participants Reporting Potential Immune-Mediated Diseases (pIMDs)
Number and percentage of patients reporting pIMDs from first vaccination up to study end for all study groups.
Measured: up to 14 months
Number of Participants with Serious Adverse Events (SAEs)
Number and percentage of patients reporting SAEs and fatal SAEs from first vaccination up to study end for all study groups.
Measured: up to 14 months
Number of Herpes Zoster Events
Number of cases of suspected HZ from study entry to last follow up date.
Measured: up to 14 months
Number of Participants Reporting Complications from HZ
Number and percentage of patients reporting any complications of HZ reported as AEs from study entry to last follow up date.
Measured: up to 14 months
Number of Participants reporting disease flares of IBD
Number and percentage of patients reporting disease flares of IBD in both study groups which will be assessed by monitoring disease activity using the Short Crohn's Activity Index (SCAI) for patients with Crohn's disease or the Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with Ulcerative colitis at the baseline visit V1, Follow up 2 (FU2), V2, V3, and V4 visit.
Measured: baseline, Visit 1 (day 1), Follow-Up 2 (up to 29 days), Visit 2 (up to 90 days), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, multicenter trial evaluating the safety and immunogenicity of recombinant herpes zoster vaccine in adults with IBD on immunosuppressive therapy.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224270
- Sponsor's protocol ID
- 2023-1727
- Other IDs
- A534250, Protocol Version 6/14/2024
- Status last verified
- Sep 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adults with Inflammatory Bowel Disease on Biologic Immunosuppressive Therapies
- ClinicalTrials.gov ID
- NCT06224270
- Acronym / sponsor ID
- 2023-1727
- Conditions
- Inflammatory Bowel Diseases, IBD
- Keywords
- immunosuppressed, Recombinant Zoster Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Jan 2024 (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.
This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.
Detailed description
Study Visits:
- Visit 1 (V1) - day 1 - blood draw, RZV dose 1
- Follow up (FU) 1 - between days 7-15
- FU 2 - between days 22-29
- Visit 2 (V2) - between days 30-90 - RZV dose 2
- FU 3 - V2 + 7-14 days
- Visit 3 (V3) - V2 + 21-50 days - blood draw
- Visit 4 (V4) - V2 + approximately 360 days - blood draw
Primary Objective:
- To demonstrate a 10% higher humoral immunogenicity following two doses of RZV in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Secondary Objectives:
- To evaluate the vaccine response rate (VRR) for anti-glycoprotein E (gE) humoral immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To characterize the anti-gE humoral immunogenicity at visit 1 (V1), visit 3 (V3), and visit 4 (V4) in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To evaluate the safety and reactogenicity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period.
- To evaluate IBD activity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period.
Tertiary/Exploratory Objectives:
- To characterize gE-specific CD4+ T-cell mediated immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
- To characterize gE-specific CD4+ T-cell mediated immune responses in patients on JAKs.
- To evaluate the VRR for anti-gE humoral immune responses in patients on Janus Kinase inhibitors (JAKs).
- To characterize the anti-gE humoral immunogenicity at V1, V3, and V4 in patients on JAKs.
- To determine the relationship between gut microbiota and response to RZV series.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, multicenter trial evaluating the safety and immunogenicity of recombinant herpes zoster vaccine in adults with IBD on immunosuppressive therapy.
| Arm | Type | Receives |
|---|---|---|
| Adults with IBD | Experimental | Biological: Adjuvanted Recombinant Zoster Vaccine (RZV) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria.
- Can provide appropriate written informed consent.
- Patient has a history of ulcerative colitis or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- Patient is receiving one of the following treatments for their IBD:
- Patient has been on stable biologic or JAK treatment for IBD for at least two months.
Key exclusion criteria (11 listed)
- Patient cannot or will not provide written informed consent.
- Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization.
- Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
- Previous vaccination against HZ or varicella within the 12M preceding the first dose of RZV.
- Occurrence of varicella or HZ per clinical history, within the 12M preceding the first dose of RZV.
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 |
|---|---|---|
| Adjuvanted Recombinant Zoster Vaccine (RZV)The RZV vaccine is indicated for prevention of herpes zoster (HZ) in adults aged 18 years and older who are or will be at increased risk of HZ. Patients with IBD on immunosuppressive therapy are at increased risk for HZ. | Biological | Adults with IBD |
Primary outcome
Geometric Mean Concentrations of Anti-gE Antibodies
Time frame: Visit 3 (between 50 and 140 days on study)
Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) at V3, following 2 doses of RZV, in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
10 secondary outcomes
Vaccine response rate (VRR)
Time frame: Visit 3 (between 50 and 140 days on study)
Seropositivity rate
Time frame: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Geometric Mean Concentrations of Anti-gE Antibodies
Time frame: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Number of Participants with Solicited Adverse Events (AEs)
Time frame: Up to 7 days after Visit 1, up to 7 days after Visit 2
Number of Participants with Unsolicited Adverse Events
Time frame: up to 30 days after Visit 1, up to 30 days after Visit 2
Number of Participants Reporting Potential Immune-Mediated Diseases (pIMDs)
Time frame: up to 14 months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: up to 14 months
Number of Herpes Zoster Events
Time frame: up to 14 months
Number of Participants Reporting Complications from HZ
Time frame: up to 14 months
Number of Participants reporting disease flares of IBD
Time frame: baseline, Visit 1 (day 1), Follow-Up 2 (up to 29 days), Visit 2 (up to 90 days), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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, MS principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjuvanted Recombinant Zoster Vaccine (RZV) in people with Inflammatory Bowel Diseases and IBD, run by University of Wisconsin, Madison at 6 sites 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 19 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: withdrawn, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Geometric Mean Concentrations of Anti-gE Antibodies (time frame: Visit 3 (between 50 and 140 days on study)). 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 25 Sep 2024.