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

NCT03798691 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2018-1037SMPH/MEDICINE/GASTROENTA534250Protocol Version 11/16/2022
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Change in Cell Mediated Immunity

  The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine.

  It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.

Secondary Outcomes (6)

• Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.

  Baseline to 6 months post-immunization 2nd dose of vaccine.

• Percent of Participants With a Change in Antibody Concentration Post Immunization

  pre-immunization to one month 2nd dose post-immunization

• Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months

  Baseline to 6 months post-immunization

• Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1

  Dose 1 (Month 0)

• Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2

  Dose 2 (anytime from Month 2 to Month 6)

Study Arms (2)

Anti-TNF monotherapy

ACTIVE COMPARATOR

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.

Biological: Shingrix

Vedolizumab

ACTIVE COMPARATOR

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.

Biological: Shingrix

Interventions

Shingrix 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.

Also known as: Recombinant zoster vaccine

Anti-TNF monotherapy; Vedolizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Boston Medical Center: collaborator

Study Sites (1)

University of Wisconsin Digestive Health Center

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Caldera F, Mogallapalli H, Abusalim AR, Farraye FA, Hayney MS. Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine in Patients With Inflammatory Bowel Disease on Vedolizumab or Anti-Tumor Necrosis Factor Therapy. Clin Transl Gastroenterol. 2025 Nov 1;16(11):e00924. doi: 10.14309/ctg.0000000000000924.

  PMID: 40995992 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Herpes Zoster

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Freddy Caldera, DO
• Organization: UW School of Medicine and Public Health

fcaldera@medicine.wisc.edu

608-628-8201

Study Officials

• Freddy Caldera, DO

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 10, 2019
• Study Start: May 28, 2019
• Primary Completion: October 12, 2023
• Study Completion: September 10, 2024
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)