← Back to Search

Cancer Vaccine

Shingrix Vaccine for Ulcerative Colitis

Phase 4

Recruiting

Led By Sharmeel K Wasan, MD

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has a history of ulcerative colitis (UC) diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months (6 months post-immunization)

Awards & highlights

Study Summary

This trial will help researchers understand if the new shingles vaccine, Shingrix, is effective in patients with UC who are also taking the immunosuppressant drug tofacitinib.

Who is the study for?

This trial is for adults with moderate to severe ulcerative colitis who are on specific treatments like Tofacitinib or anti-TNF therapy. They must have had chickenpox before, as proven by medical history or a positive antibody test. People can't join if they've had any herpes zoster vaccine, allergies to the vaccine components, are pregnant, have other chronic conditions affecting immunity, or are on certain unapproved drugs.Check my eligibility

What is being tested?

The study tests the Shingrix vaccine's effectiveness in UC patients taking immunosuppressants like Tofacitinib. It aims to see if their immune response is strong enough compared to non-immunosuppressed individuals and those on different therapies.See study design

What are the potential side effects?

While not specified here, common side effects of vaccines like Shingrix may include pain at the injection site, fatigue, headache, muscle pain, fever and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months (6 months post-immunization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months (6 months post-immunization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months (6 months post-immunization) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in the immunogenicity of the herpes zoster subunit vaccine in UC patients

Secondary outcome measures

Antibodies

Change in disease activity

Sustained T cell response

+5 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Acute pulmonary embolism and acute deep vein thrombosis

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: UC patients on tofacitinib monotherapyExperimental Treatment1 Intervention

Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.

Group II: UC patients on anti-TNF monotherapyActive Control1 Intervention

Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy (adalimumab, golimumab, certolizumab, infliximab)and will receive Shingrix vaccine.

Group III: UC patients on anti-TNF and a thiopurineActive Control1 Intervention

Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy (adalimumab, golimumab, certolizumab, infliximab) and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.

Group IV: UC pts. on aminosalicylates or off immunomodulatory therapyActive Control1 Intervention

Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.

0 / 1Eligibility criteria met