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Virus Vaccine

Shingrix Vaccine for Inflammatory Bowel Disease

Phase 4
Waitlist Available
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
Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
History of primary varicella infection (chicken pox) confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be done at months 1, 2 and 3.
Awards & highlights

Study Summary

This trial found that the HZ vaccine was effective in reducing the incidence of HZ among patients with IBD, with the highest efficacy in those with Crohn's disease.

Who is the study for?
This trial is for adults aged 18-70 with Inflammatory Bowel Disease (IBD), specifically Ulcerative Colitis or Crohn's, who have been on stable IBD treatment for at least three months. Participants must have had chickenpox before and be receiving certain IBD treatments without recent steroids, immunomodulators, or other vaccines that could affect the immune response.Check my eligibility
What is being tested?
The study tests Shingrix vaccine's effectiveness in preventing shingles among IBD patients treated with Vedolizumab. It aims to understand if this new non-live vaccine can safely boost immunity against herpes zoster in those who are often on immunosuppressants due to their condition.See study design
What are the potential side effects?
Shingrix may cause pain at the injection site, muscle pain, tiredness, headache, chills, fever, and stomach problems. These side effects typically last a short time and indicate that the body is building protection against shingles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on either anti-TNF or Vedolizumab treatment for my IBD.
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I have had chicken pox in the past.
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I have been diagnosed with ulcerative colitis or Crohn's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the baseline visit and one month after receipt of each vaccine
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the baseline visit and one month after receipt of each vaccine 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 cell mediated immunity
Secondary outcome measures
Incidence of Vaccine related adverse effects
Incidence of change in disease activity post immunization
Percent of participants with a change in antibody concentration post immunization
+2 more

Trial Design

2Treatment groups
Active Control
Group I: VedolizumabActive Control1 Intervention
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine. 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.
Group II: Anti-TNF monotherapyActive Control1 Intervention
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. 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.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,554 Total Patients Enrolled
Boston Medical CenterOTHER
383 Previous Clinical Trials
871,116 Total Patients Enrolled

Media Library

Shingrix (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03798691 — Phase 4
Shingles Research Study Groups: Vedolizumab, Anti-TNF monotherapy
Shingles Clinical Trial 2023: Shingrix Highlights & Side Effects. Trial Name: NCT03798691 — Phase 4
Shingrix (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03798691 — Phase 4

Frequently Asked Questions

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

Does this research represent the inaugural evaluation of its type?

"Presently, 23 countries are hosting 15 distinct trials for Anti-TNF monotherapy. The first such investigation began in 2014 and was backed by Bristol-Myers Squibb; 130 subjects were involved and the Phase 2 drug approval phase concluded successfully. Since then, a further 26 experiments have been conducted."

Answered by AI

Am I eligible to become a participant in this clinical experiment?

"To participate in this medical research, volunteers must be between 18 and 70 years old with a confirmed diagnosis of herpes zoster. The researchers are looking for approximately thirty individuals to join the trial."

Answered by AI

Are there still opportunities for enrolment in this trial?

"Affirmative. According to clinicaltrials.gov, the details of this study were first posted on May 28th 2019 and have been modified most recently on November 16th 2022. This research initiative is searching for 30 individuals at one trial site."

Answered by AI

To what extent is patient participation in this experiment being maximized?

"That is correct. According to information on clinicaltrials.gov, this medical trial was initially posted on May 28th 2019 and the most recent update took place November 16th 2022. The study requires 30 individuals to join from a single site."

Answered by AI

Has Anti-TNF monotherapy been tested in prior research studies?

"Currently, there are 15 experiments investigating Anti-TNF monotherapy with 4 of these in the crucial Phase 3. Madison, Wisconsin is hosting several Anti-TNF trials while 206 other medical centres have initiated studies on this therapy."

Answered by AI

Does this medical experiment include geriatric participants?

"This trial is open to those aged 18 through 70, as stipulated by the specified entry requirements."

Answered by AI

Has the FDA granted approval to Anti-TNF monotherapy treatments?

"Anti-TNF monotherapy has a score of 3 on our estimate, as the drug is already approved and in its fourth phase clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
2019. "Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03798691.
All > Inflammatory Bowel Disease > Shingles
~6 spots leftby Apr 2025
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