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Cancer Vaccine

Shingrix Vaccine for Ulcerative Colitis

Q: How many individuals are participating in this clinical experiment?

Affirmative, according to clinicaltrials.gov, this research is actively recruiting patients since it was initially posted on July 31st 2019 and revised for the last time on September 20th 2022. It hopes to enroll 100 participants from one trial center.

Q: Is this clinical research enrolling participants yet?

This trial is actively seeking enrollees, as reported on clinicaltrials.gov. It was initially advertised in July 2019 and has been updated most recently this September.

Q: Is this medical study a pioneering endeavour?

Presently, 16 clinical trials for SHINGRIX are underway in 92 cities and 23 countries. Bristol-Myers Squibb initiated the first investigation of this medication back in 2014 with 130 participants. Since then, 56 further research studies have been conducted to progress it through Phase 2 drug approval.

Q: What other research endeavors have been undertaken involving SHINGRIX?

As of now, there are 16 studies delving into SHINGRIX with 4 trials in their third phase. Aurora, <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> is one of the many sites conducting these experiments; altogether 207 locations have joined this research initiative.

Q: Has the SHINGRIX vaccine been given clearance by the FDA?

SHINGRIX has been approved, so our team's estimation of its safety is 3 out of a maximum score of 3.

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 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

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

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

384 Previous Clinical Trials

871,530 Total Patients Enrolled

Sharmeel K Wasan, MDPrincipal InvestigatorBoston Medical Center

1 Previous Clinical Trials

173 Total Patients Enrolled

Media Library

SHINGRIX (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03591770 — Phase 4

Inflammatory Bowel Disease Research Study Groups: UC patients on tofacitinib monotherapy, UC patients on anti-TNF monotherapy, UC patients on anti-TNF and a thiopurine, UC pts. on aminosalicylates or off immunomodulatory therapy

Inflammatory Bowel Disease Clinical Trial 2023: SHINGRIX Highlights & Side Effects. Trial Name: NCT03591770 — Phase 4

SHINGRIX (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03591770 — Phase 4

Frequently Asked Questions

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

How many individuals are participating in this clinical experiment?

"Affirmative, according to clinicaltrials.gov, this research is actively recruiting patients since it was initially posted on July 31st 2019 and revised for the last time on September 20th 2022. It hopes to enroll 100 participants from one trial center."

Answered by AI

Is this clinical research enrolling participants yet?

"This trial is actively seeking enrollees, as reported on clinicaltrials.gov. It was initially advertised in July 2019 and has been updated most recently this September."

Answered by AI

Is this medical study a pioneering endeavour?

"Presently, 16 clinical trials for SHINGRIX are underway in 92 cities and 23 countries. Bristol-Myers Squibb initiated the first investigation of this medication back in 2014 with 130 participants. Since then, 56 further research studies have been conducted to progress it through Phase 2 drug approval."

Answered by AI

What other research endeavors have been undertaken involving SHINGRIX?

"As of now, there are 16 studies delving into SHINGRIX with 4 trials in their third phase. Aurora, Colorado is one of the many sites conducting these experiments; altogether 207 locations have joined this research initiative."

Answered by AI