The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib

Trial Information
Who is this study for? Patients with moderate to severe ulcerative colitis
What treatments are being studied? Shingrix
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
Summary

Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their underlying disease. Patients with UC are also often treated with immunosuppressants, and research has shown that IBD patients on immunosuppressants have an impaired immune response to vaccination in comparison to immunocompetent controls. Because UC patients are often treated with immunosuppressants, the live HZ vaccine was not recommended in these patients. Shingrix, however, is a new inactivated vaccine recently approved by the FDA for prevention of HZ in adults age 50 and older, and Shingrix should be safe to administer in IBD patients because it does not contain live HZ virus. Data on efficacy of the Shingrix vaccine also appears promising in immunocompromised patients. Tofacitinib citrate (Xeljanz), an immunosuppressant that works by inhibiting the Janus kinase pathway, is currently approved for treatment of certain inflammatory diseases such as rheumatoid arthritis and psoriasis. The drug is currently awaiting FDA-approval for use in moderate-to-severe UC but has been used off-label in various settings. Notably, tofacitinib was associated with an increased risk of HZ in patients with rheumatoid arthritis and psoriasis. The research hypothesis is that UC patients on tofacitinib will mount an adequate response and that the response will be slightly diminished compared to non-immunosuppressed IBD patients, comparable to those on anti-tumor necrosis alpha (anti-TNF) monotherapy, and superior to those on anti-TNF therapy in combination with a thiopurine. Strong cell mediated immunity is shown to prevent reactivation of HZ, and demonstrating a robust immune response to Shingrix may serve as a surrogate for a reduced risk of developing shingles and might alleviate prescribers' concerns regarding the use of tofacitinib. The results will also serve as pilot data to inform larger future studies evaluating the actual risk of developing shingles in patients on tofacitinib who receive Shingrix.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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

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

• 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.

Where is this trial taking place?
United States
Massachusetts
Boston Medical Center
Recruiting
Boston
Who do I contact about this trial?
Primary
Sharmeel K Wasan, MD
sharmeel.wasan@bmc.org
(617) 638-6116
Backup
Jean Mendez
jean.mendez@bmc.org
When is this trial taking place?
Start Date: July 31, 2019
Estimated Completion Date: December 2022
How many participants will be in this trial?
Target number of participants: 100
What treatment is being studied in this trial?
Experimental: UC patients on tofacitinib monotherapy
Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.
Active Comparator: UC patients on anti-TNF monotherapy
Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy (adalimumab, golimumab, certolizumab, infliximab)and will receive Shingrix vaccine.
Active Comparator: UC patients on anti-TNF and a thiopurine
Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy (adalimumab, golimumab, certolizumab, infliximab) and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.
Active Comparator: UC pts. on aminosalicylates or off immunomodulatory therapy
Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov

A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Who is this study for:Older adult patients with a Varicella Infection and Ulcerative Colitis or Crohn's Disease
Status:Recruiting
Start Date:May 28, 2019
Study Drug:Shingrix Herpes Zoster Vaccine
Study Type:Biological
Phase: Phase 4
Persistence of Protection Conferred by Shingrix Against Herpes Zoster
Who is this study for:Older adult patients with Herpes Zoster Infection
Status:Recruiting
Start Date:July 28, 2020
Study Drug:Shingrix
Study Type:Biological
Phase: Phase 1
SHINGRIX-Systems Biology of Zoster Vaccine Recombinant, Adjuvanted
Who is this study for:Patients with Zoster Varicella, Shingles, Chicken Pox
Status:Recruiting
Start Date:November 14, 2019
Study Drug:Shingrix�
Study Type:Biological
Phase: Phase 2