Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT03591770
• Date of registration: 09/07/2018
• Prospective Registration: Yes
• Primary sponsor: Boston Medical Center
• Public title: Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
• Scientific title: The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
• Date of first enrolment: July 31, 2019
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03591770
• 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

Contacts

• Name: Sharmeel K Wasan, MD

• Name: Jean Mendez, MD

• Name: Sharmeel K Wasan, MD
• Affiliation: Boston Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Proof of primary varicella infection (chicken pox) either by appropriate history (as
defined by ACIP) or otherwise confirmed with a positive VZV IgG antibody level

2. Patient has a history of ulcerative colitis (UC) diagnosed by standard clinical,
radiographic, endoscopic, and histopathologic criteria

3. Patient is receiving one of the following treatments for their UC:

Group A: Tofacitinib monotherapy, Group B: Anti-TNF monotherapy (adalimumab, golimumab,
certolizumab pegol, infliximab), Group C: Anti-TNF combination therapy with a thiopurine (6
mercaptopurine, azathioprine), Group D: 5-aminosalicylates or other non-immunomodulatory
therapy.

Exclusion Criteria:

1. Previous receipt of any HZ vaccine

2. Allergy to zoster vaccine or a component of the vaccine

3. Other underlying chronic medical conditions that could affect immunogenicity to
vaccines (rheumatoid arthritis, psoriasis etc.)

4. History of herpes zoster infection or post herpetic neuralgia

5. Patient cannot or will not provide written informed consent

6. Patient is on a non-licensed or experimental immunomodulator

7. Patient is on methotrexate

8. Patient has received immunoglobulin therapy or blood products with the past month

9. Currently pregnant



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Intervention(s)

Biological: SHINGRIX

Primary Outcome(s)

Change in the immunogenicity of the herpes zoster subunit vaccine in UC patients [Time Frame: Baseline and approximately 90 days]

Secondary Outcome(s)

Change in disease activity [Time Frame: Baseline and 8 months (6 months post-immunization)]

Change in antibody response [Time Frame: Baseline to 1 month post-immunization]

Sustained T cell response [Time Frame: Baseline to 6 months post-immunization]

Vaccine adverse effects at 1 month [Time Frame: 1 month]

Vaccine adverse effects at 2 months [Time Frame: 2 months]

Vaccine adverse effects at 8 months (6 months post-immunization) [Time Frame: 8 months (6 months post-immunization)]

Sustained antibody response [Time Frame: Baseline to 6 months post-immunization]

Vaccine adverse effects at 3 months (1 month post-immunization) [Time Frame: 3 months (1 months post-immunization)]

Secondary ID(s)

H-37673

Source(s) of Monetary Support

Please refer to primary and secondary sponsors