Clinical trial NCT03798691: Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Official title: A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Herpes Zoster
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
First posted: 2019-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cell Mediated Immunity
timeFrame: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.
Secondary outcomes:
measure: Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.
timeFrame: Baseline to 6 months post-immunization 2nd dose of vaccine.
measure: Percent of Participants With a Change in Antibody Concentration Post Immunization
timeFrame: pre-immunization to one month 2nd dose post-immunization
measure: Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months
timeFrame: Baseline to 6 months post-immunization
measure: Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
timeFrame: Dose 1 (Month 0)
measure: Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
timeFrame: Dose 2 (anytime from Month 2 to Month 6)
measure: Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
timeFrame: at the baseline visit and one month after receipt of each vaccine
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Digestive Health Center
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Freddy Caldera, DO
role: PRINCIPAL_INVESTIGATOR
References: