Safety and Immune Response of the COVID 19 Vaccine in Patients with Inflammatory Bowel Disease

Overview

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.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Francis Farraye, M.D., M.S.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Francis Farraye, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials