Phase 4
N=33
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Inflammatory Bowel Diseases · Crohn Disease · Ulcerative Colitis · Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT03798691 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Cell Mediated Immunity — 33; 33; 33; 50 cells per million — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Shingrix (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cell Mediated Immunity |
33; 33; 33; 50 | 0.16 |
| SECONDARY Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization. |
15; 15 | — |
| SECONDARY Percent of Participants With a Change in Antibody Concentration Post Immunization |
15; 15 | — |
| SECONDARY Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months |
15; 15 | — |
| SECONDARY Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 |
7; 1; 0; 0; 6; 0 | — |
| SECONDARY Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 |
5; 1; 2; 0; 3; 3 | — |
| SECONDARY Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03798691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.