Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease

Overview

About this study

The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine. This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity at 6 and 12 months after completion of vaccination. The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

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:

Adults with established inflammatory bowel disease, age 18-85 years.
On one of the following treatment regimens at both the time of immunization and at time of recruitment:
- Group A non-biologic group: mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.
- Group B: Anti-TNF Therapy Group:
- - Maintenance monotherapy: infliximab (at least 8 every 8 weeks), golilumumab (at least monthly), adalilumab (at least every 2 weeks), or certolizumab (at least monthly);
  - Combination Therapy: Anti-TNF Combination Therapy Group (approximately 40-50% of the group): on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg.
- Group C: Ustekinumab on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
- Group D: Vedolizumab Therapy Group: Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.

Exclusion Criteria:

Individuals under 18 or over 85 years of age.
Not diagnosed with inflammatory bowel disease.

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	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Francis Farraye, M.D., M.S.	Open for enrollment	Contact information: Clinical Studies Unit (904) 953-2255

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available

Clinical Trials