Adults 18 to 70, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cell Mediated ImmunityPrimary· 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.
Pre-Vaccine
Group
Value
95% CI
Vedolizumab
33
5 – 58
Anti-TNF Monotherapy
33
13 – 88
One month after series completion of two dose series
Group
Value
95% CI
Vedolizumab
33
17 – 91
Anti-TNF Monotherapy
50
36 – 193
Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.Secondary· Baseline to 6 months post-immunization 2nd dose of vaccine.
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
Group
Value
95% CI
Vedolizumab
15
Anti-TNF Monotherapy
15
Percent of Participants With a Change in Antibody Concentration Post ImmunizationSecondary· pre-immunization to one month 2nd dose post-immunization
A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration.
Group
Value
95% CI
Vedolizumab
15
Anti-TNF Monotherapy
15
Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 MonthsSecondary· Baseline to 6 months post-immunization
Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed.
Group
Value
95% CI
Vedolizumab
15
Anti-TNF Monotherapy
15
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1Secondary· Dose 1 (Month 0)
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.
Any Systemic Adverse Effect
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
7
Vedolizumab Dose 1: Grade 2
1
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
6
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Headaches
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
6
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
3
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Plugged ear
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
1
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
0
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Intermittent fever/chills
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
3
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
2
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Lymphadenopathy
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
0
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
1
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Congestion
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
0
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
1
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Fatigue
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
5
Vedolizumab Dose 1: Grade 2
0
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
2
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Myalgias/joint pain
Group
Value
95% CI
Vedolizumab Dose 1: Grade 1
2
Vedolizumab Dose 1: Grade 2
1
Vedolizumab Dose 1: Grade 3
0
Vedolizumab Dose 1: Grade 4
0
Anti-TNF Monotherapy Dose 1: Grade 1
1
Anti-TNF Monotherapy Dose 1: Grade 2
0
Anti-TNF Monotherapy Dose 1: Grade 3
0
Anti-TNF Monotherapy Dose 1: Grade 4
0
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2Secondary· Dose 2 (anytime from Month 2 to Month 6)
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.
Any Systemic Adverse Effect
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
5
Vedolizumab Dose 2: Grade 2
1
Vedolizumab Dose 2: Grade 3
2
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
3
Anti-TNF Monotherapy Dose 2: Grade 2
3
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Headaches
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
3
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
0
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
1
Anti-TNF Monotherapy Dose 2: Grade 2
1
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Plugged ear
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
0
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
0
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
0
Anti-TNF Monotherapy Dose 2: Grade 2
0
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Intermittent fever/chills
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
4
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
1
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
1
Anti-TNF Monotherapy Dose 2: Grade 2
2
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Lymphadenopathy
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
0
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
0
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
0
Anti-TNF Monotherapy Dose 2: Grade 2
0
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Congestion
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
0
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
0
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
0
Anti-TNF Monotherapy Dose 2: Grade 2
0
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Fatigue
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
4
Vedolizumab Dose 2: Grade 2
1
Vedolizumab Dose 2: Grade 3
0
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
1
Anti-TNF Monotherapy Dose 2: Grade 2
1
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Myalgias/joint pain
Group
Value
95% CI
Vedolizumab Dose 2: Grade 1
6
Vedolizumab Dose 2: Grade 2
0
Vedolizumab Dose 2: Grade 3
1
Vedolizumab Dose 2: Grade 4
0
Anti-TNF Monotherapy Dose 2: Grade 1
1
Anti-TNF Monotherapy Dose 2: Grade 2
0
Anti-TNF Monotherapy Dose 2: Grade 3
0
Anti-TNF Monotherapy Dose 2: Grade 4
0
Number of Participants Experiencing a Change in Disease Activity Post Immunization ReportedSecondary· at the baseline visit and one month after receipt of each vaccine
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.
baseline
Group
Value
95% CI
Vedolizumab
0
Anti-TNF Monotherapy
0
1 month post-dose 1
Group
Value
95% CI
Vedolizumab
0
Anti-TNF Monotherapy
0
1 month post-dose 2
Group
Value
95% CI
Vedolizumab
0
Anti-TNF Monotherapy
0
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 12 months post second dose (approximately 425 days on study).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07205796 — A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) i
· Phase 2
· not yet recruiting
NCT06763783 — Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases
· Phase 4
· enrolling by invitation
NCT06409494 — Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years
· Phase 1
· active not recruiting
NCT06375512 — A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Health
· Phase 1
· completed
NCT05991427 — A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 2 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03798691.