Safety and Immune Response of the COVID 19 Vaccine in Patients with Inflammatory Bowel Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-012838
About this study
This will be a prospective study of patients with IBD at Mayo Clinic initially in Jacksonville with possible subsequent extension to other Mayo sites. We will evaluate the immunogenicity of commercially available COVID-19 vaccines and compare vaccine response among the groups based on their immunosuppressive regimens. We will divide the immunosuppressive regimens into presumed high vaccine responders Group A and presumed low vaccine responders Group B. We will also assess for adverse reactions to the vaccine and compare with the reported rates in the clinical trials that led to approval of these vaccines.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participants will be ≥ 18 years of age.
- Established diagnosis of IBD on one of the following immunosuppressive regimens divided based on previous vaccine studies.
- Group A (high vaccine responders):
- thiopurine monotherapy;
- vedolizumab mono or combination therapy;
- ustekinumab mono or combination therapy;
- patients on mesalamine or no therapy.
- Group B (Low vaccine responders):
- Anti-TNF monotherapy;
- anti-TNF combination therapy;
- tofacitinib;
- current use of systemic corticosteroids.
Exclusion Criteria:
- Previously received COVID 19 vaccine.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available