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Cancer Vaccine

Shingles Vaccine for Inflammatory Bowel Disease

Phase 4
Waitlist Available
Led By Freddy Caldera, DO, MS
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Anti-TNF therapy (infliximab, adalimumab, certolizumab, or golimumab) on anti-TNF monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6-Mercaptopurine (6MP) 0.5mg/kg
Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria
Must not have
Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection
Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test the safety and effectiveness of a vaccine for shingles in 264 patients with inflammatory bowel disease who are taking medication that weakens their immune system. The study will take place at

Who is the study for?
Adults aged 19-85 with Inflammatory Bowel Disease (IBD) on specific immunosuppressive therapies can join this study. They must be in stable remission, not have used steroids recently, and agree to contraception if applicable. Those with recent vaccinations or infections, certain immune conditions, or suspected noncompliance are excluded.
What is being tested?
The trial is testing the safety and immune response to the Adjuvanted Recombinant Zoster Vaccine (RZV) in patients with IBD who are undergoing immunosuppressive therapy. Participants will be monitored for up to 14 months across multiple centers.
What are the potential side effects?
While the side effects aren't detailed here, vaccines like RZV may cause pain at injection site, headache, fatigue, muscle pain, shivering, fever, and upset stomach. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on anti-TNF therapy alone or with methotrexate, azathioprine, or 6MP.
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I am between 19 and 85 years old and have been diagnosed with IBD.
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I have been diagnosed with ulcerative colitis or Crohn's disease.
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I am taking a Janus Kinase Inhibitor, either tofacitinib (5mg twice daily) or upadactinib (15mg twice daily).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV, immune diseases, widespread cancer, or untreated infections.
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I have been on steroids for more than 3 days in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Geometric Mean Concentrations of Anti-gE Antibodies
Number of Herpes Zoster Events
Number of Participants Reporting Complications from HZ
+7 more
Other study objectives
Geometric Mean Concentrations of Anti-gE Antibodies by Alpha Diversity of Microbiome
Geometric Mean Concentrations of Anti-gE Antibodies in Patients on JAKs
Number of gE-specific CD4 cells expressing at least 2 activation markers
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adults with IBDExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,226 Previous Clinical Trials
3,168,674 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,802 Previous Clinical Trials
8,378,002 Total Patients Enrolled
Freddy Caldera, DO, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
303 Total Patients Enrolled
~0 spots leftby Sep 2027
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