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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/MEDICINE/GASTROENT | Other Identifier | UW Madison | |
| A534250 | Other Identifier | UW Madison | |
| Protocol Version 11/16/2022 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Boston Medical Center | OTHER |
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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.
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:
Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shingrix | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 6 months post-immunization 2nd dose of vaccine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Caldera, DO | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Digestive Health Center | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40995992 | Derived | 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. |
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Participants were enrolled at UW Health from May 2019 to July 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab | 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. Shingrix: 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. |
| FG001 | Anti-TNF Monotherapy | 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. Shingrix: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | cells per million | It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. |
|
up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vedolizumab: Dose 1 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Freddy Caldera, DO | UW School of Medicine and Public Health | 608-628-8201 | fcaldera@medicine.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Mar 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
|
| 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. |
| 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. | 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. | 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. | 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. | at the baseline visit and one month after receipt of each vaccine |
| Anti-TNF Monotherapy |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Participants with Crohn's Disease | Count of Participants | Participants |
|
| Current Irritable Bowel Disease (IBD) Medication | Count of Participants | Participants |
|
| Previous IBD Medications | Count of Participants | Participants |
|
| Positive history of herpes zoster | Count of Participants | Participants |
|
| Length of disease | Median | Inter-Quartile Range | months |
|
| Previous IBD surgery | Count of Participants | Participants |
|
| Steroid use in past year | Count of Participants | Participants | No |
|
| Charlson Comorbidity Score | None: score 0 Mild: scores of 1-2 Moderate: scores of 3-4 Severe: scores of 5 or higher (up to 37) | Median | Inter-Quartile Range | units on a scale |
|
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.
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Baseline to 6 months post-immunization 2nd dose of vaccine. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | pre-immunization to one month 2nd dose post-immunization |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline to 6 months post-immunization |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Dose 1 (Month 0) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Dose 2 (anytime from Month 2 to Month 6) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | at the baseline visit and one month after receipt of each vaccine |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 10 |
| 15 |
| EG001 | Anti-TNF Monotherapy: Dose 1 | 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. | 0 | 15 | 0 | 15 | 13 | 15 |
| EG002 | Vedolizumab: Dose 2 | 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. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG003 | Anti-TNF Monotherapy: Dose 2 | 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. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG004 | Vedolizumab: 6 Months Post Follow up | Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG005 | Anti-TNF Monotherapy: 6 Months Post Follow up | Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG006 | Vedolizumab: 12 Months Post Follow up | Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG007 | Anti-TNF Monotherapy: 12 Months Post Follow up | Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. | 0 | 15 | 0 | 15 | 0 | 15 |
| Plugged Ear | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Intermittent Fever or Chills | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Lymphadenopathy | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Congestion | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Myalgias or Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Pain or Soreness | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Warmth | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| Headaches |
|
| Plugged ear |
|
| Intermittent fever/chills |
|
| Lymphadenopathy |
|
| Congestion |
|
| Fatigue |
|
| Myalgias/joint pain |
|
| Any Local Adverse Effect |
|
| Pain/Soreness |
|
| Pruritus |
|
| Erythema |
|
| Swelling |
|
| Warmth |
|
| Headaches |
|
| Plugged ear |
|
| Intermittent fever/chills |
|
| Lymphadenopathy |
|
| Congestion |
|
| Fatigue |
|
| Myalgias/joint pain |
|
| Any Local Adverse Effect |
|
| Pain/Soreness |
|
| Pruritus |
|
| Erythema |
|
| Swelling |
|
| Warmth |
|
| 1 month post-dose 2 |
|