Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Inflammatory Bowel Diseases
About this trial
This is an interventional basic science trial for Inflammatory Bowel Diseases focused on measuring Shingrix vaccine, tofacitinib monotherapy, anti-TNF monotherapy, anti-TNF agent, thiopurine, aminosalicylates
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous receipt of any HZ vaccine
- Allergy to zoster vaccine or a component of the vaccine
- Other underlying chronic medical conditions that could affect immunogenicity to vaccines (rheumatoid arthritis, psoriasis etc.)
- History of herpes zoster infection or post herpetic neuralgia
- Patient cannot or will not provide written informed consent
- Patient is on a non-licensed or experimental immunomodulator
- Patient is on methotrexate
- Patient has received immunoglobulin therapy or blood products with the past month
- Currently pregnant
Sites / Locations
- Boston Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Active Comparator
UC patients on tofacitinib monotherapy
UC patients on anti-TNF monotherapy
UC patients on anti-TNF and a thiopurine
UC pts. on aminosalicylates or off immunomodulatory therapy
Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.
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.
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.
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.