Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2024-09-10

Brief Summary

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Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.

Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.

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Detailed Description

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The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy.

The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination.

The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab.

The study population will include adult patients aged 18 to 70 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics. There is no randomization or use of placebo in this study. Two study groups will be established:

* Group A: Patients with IBD on anti-TNF monotherapy
* Group B: Patients with IBD on vedolizumab monotherapy

Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics.

Conditions

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Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Herpes Zoster

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anti-TNF monotherapy

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.

Group Type ACTIVE_COMPARATOR

Shingrix

Intervention Type BIOLOGICAL

Biological: SHINGRIX

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older.

SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

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.

Vedolizumab

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 Type ACTIVE_COMPARATOR

Shingrix

Intervention Type BIOLOGICAL

Biological: SHINGRIX

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older.

SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

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.

Interventions

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Shingrix

Biological: SHINGRIX

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older.

SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Recombinant zoster vaccine

Eligibility Criteria

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Inclusion Criteria

1. Patient is between the ages of 18-70 years, inclusive.
2. 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
3. Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
4. Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
5. Patient has been on stable treatment for IBD for at least three months.

Exclusion Criteria

1. Previous receipt of any HZ vaccine
2. Allergy to zoster vaccine or a component of it
3. Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.)
4. History of herpes zoster or post herpetic neuralgia within the past year.
5. Patient cannot or will not provide written informed consent.
6. Patient is being administered immunomodulators currently or within the past three months
7. Patient has been taking any dose of oral or intravenous steroids within 30 days prior to immunization.
8. Patient has received polyclonal immunoglobulin therapy or blood products within the last year.
9. Patient is pregnant per self-reporting or older than age 70 years
10. Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No