ShinGrix Vaccine Study - 

​Immunogenicity of herpes zoster subunit vaccine among
ulcerative colitis patients treated with tofacitinib and other
immunosuppressive regimens

PIs: Meenakshi Bewtra, MD, PhD, MPH
Collaboration with PFIZER​
For potential eligibility and interested patients, ​contact: [email protected]
In collaboration with Pfizer Pharmaceuticals, University of Pennsylvania is doing research to measure how the immune system responds to Shingrix, the new shingles vaccine, in patients with ulcerative colitis who are treated with different medications. Shingrix is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older. 
The purpose of this research is to study how the immune system responds to Shingrix, the new shingles vaccine, in patients with ulcerative colitis who are on medications that suppress the immune system. Unlike the previous shingles vaccine Zostavax, the new Shingrix vaccine does not contain live portions of the virus and as a result can be given to patients with suppressed immune systems. Previous studies have shown that patients with suppressed immune systems gain less protection from vaccinations, and the data for patients treated with tofacitinib is unclear. By measuring markers of immunity before, 1 month after, and 6 months after receiving the Shingrix vaccine, this study will demonstrate how much protection Shingrix provides in patients with ulcerative colitis on medications that suppress the immune system.​​
Inclusion Criteria
Exclusion Criteria
  • Age 18 or older
  • Proof of primary varicella infection (chicken pox) either by appropriate history or, if history is atypical or mild, a positive VZV IgG antibody level
  •  Patient has a history of UC diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
  • Patient is receiving one of the following treatments for their UC
    • Tofacitinib monotherapy
    • Anti-TNF monotherapy (adalimumab, golimumab, infliximab)
    • Anti-TNF monotherapy plus a thiopurine (6 mercaptopurine, azathioprine)
    • No therapy or 5-aminosalicylates
• Previous receipt of any HZ vaccine
• Allergy to zoster vaccine or a component of the vaccine
• Other underlying chronic medical conditions that are immunosuppressive or could affect
immunogenicity to vaccines (HIV, transplant recipient on anti-rejection drugs, 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 is on steroids
• Patient has received immunoglobulin therapy or blood products with the past month
• Patient is pregnant or lactating