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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
Must not have
Patient has received polyclonal immunoglobulin therapy or blood products within the last year.
Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be done at months 1, 2 and 3.
Awards & highlights
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.
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.
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 belowSelect...
I am on either anti-TNF or Vedolizumab treatment for my IBD.
Select...
I have had chicken pox in the past.
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I have been diagnosed with ulcerative colitis or Crohn's disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received immunoglobulin therapy or blood products in the past year.
Select...
I am able to understand and consent to the trial on my own.
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I have received a shingles vaccine in the past.
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I am pregnant or I am over 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the baseline visit and one month after receipt of each vaccine
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the baseline visit and one month after receipt of each vaccine
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cell mediated immunity
Secondary study objectives
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 moreTrial 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
1,210 Previous Clinical Trials
3,157,706 Total Patients Enrolled
Boston Medical CenterOTHER
395 Previous Clinical Trials
875,496 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the shingles vaccine or any part of it.I have taken steroids orally or through an IV in the last 30 days.I have received immunoglobulin therapy or blood products in the past year.I am able to understand and consent to the trial on my own.I am on either anti-TNF or Vedolizumab treatment for my IBD.I am between 18 and 70 years old.You have had shingles or nerve pain after having shingles in the past year.I have taken immunomodulators in the last 3 months.I have a chronic condition like rheumatoid arthritis that could affect vaccine response.I have had chicken pox in the past.I have been on a consistent treatment for IBD for 3+ months.I have received a shingles vaccine in the past.I am pregnant or I am over 70 years old.I have been diagnosed with ulcerative colitis or Crohn's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Vedolizumab
- Group 2: Anti-TNF monotherapy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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