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Cancer Vaccine

Adults with IBD 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Geometric Mean Concentrations of Anti-gE Antibodies

Number of Herpes Zoster Events

Number of Participants Reporting Complications from HZ

+7 more

Other outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adults with IBDExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,183 Previous Clinical Trials

3,167,707 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,753 Previous Clinical Trials

8,069,194 Total Patients Enrolled

Freddy Caldera, DO, MSPrincipal InvestigatorUniversity of Wisconsin, Madison

3 Previous Clinical Trials

392 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this clinical trial?

"To be eligible for participation in this clinical trial, candidates must have a diagnosis of inflammatory bowel disease and fall between the age range of 19 to 85. A total of 264 individuals will be enrolled in this study."

Answered by AI

In how many medical facilities is this examination being conducted?

"At present, this study is actively enrolling patients from a total of 6 sites. These include locations in Jacksonville, Baltimore, Chapel Hill, as well as other undisclosed areas. To minimize travel obligations for participants, it is advisable to choose the site nearest to their location when considering participation."

Answered by AI

Is the enrollment for this study currently open?

"Apologies for the misunderstanding. According to clinicaltrials.gov, this specific trial is no longer actively seeking participants. However, there are currently 198 other ongoing clinical trials that are actively recruiting eligible individuals."

Answered by AI

Is there an age criterion for potential participants in this study, specifically excluding individuals under 35 years old?

"Patients aged 19 and above, but below the age of 85 are eligible for participation in this study."

Answered by AI

Has the Food and Drug Administration given its official endorsement to the use of Adults with Inflammatory Bowel Disease?

"With this being a Phase 4 trial, which indicates that the treatment has already received approval, our team at Power rates the safety level for adults with IBD as a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Response to Zoster Vaccine in Adults With Inflammatory Bowel Disease Treated With Medications

2024. "Study of Response to Zoster Vaccine in Adults With Inflammatory Bowel Disease Treated With Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06224270.

All > Inflammatory Bowel Disease