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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT03798691
Date of registration: 02/01/2019
Prospective Registration: Yes
Primary sponsor: University of Wisconsin, Madison
Public title: Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Scientific title: A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Date of first enrolment: May 28, 2019
Target sample size: 30
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Name:     Lindsey Leudke
Telephone: 608-262-5404
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient is between the ages of 50-70 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

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

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.

Age minimum: 50 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Herpes Zoster
Inflammatory Bowel Diseases
Ulcerative Colitis
Biological: Shingrix
Primary Outcome(s)
Change in cell mediated immunity [Time Frame: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.]
Secondary Outcome(s)
Incidence of change in disease activity post immunization [Time Frame: at the baseline visit and one month after receipt of each vaccine]
Incidence of Vaccine related adverse effects [Time Frame: This will be done at months 1, 2 and 3.]
Percent of participants with a change in antibody concentration post immunization [Time Frame: pre-immunization to one month 2nd dose post-immunization]
Percent of participants with a change in antibody concentration that is sustained at 6 months [Time Frame: Baseline to 6 months post-immunization]
Percent of participants with sustained cell mediated immunity measured via ELISPOT after immunization. [Time Frame: Baseline to 6 months post-immunization 2nd dose of vaccine.]
Secondary ID(s)
Protocol Version 10/10/2018
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Boston Medical Center
Ethics review
Results available:
Date Posted:
Date Completed:
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