Status:
COMPLETED
Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
IBD
Covid19 Vaccine
Eligibility:
All Genders
18-85 years
Brief Summary
The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressi...
Detailed Description
COVID-19 has a variable spectrum of illness with the majority of infection resulting in asymptomatic or mild disease. However certain healthy adults and immunosuppressed populations can develop severe...
Eligibility Criteria
Inclusion
- For mRNA cohort:
- Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- On one of the following treatment regimens:
- Group A: Non-systemic immunosuppressive Group at least 75 participants
- Mesalamine monotherapy or no therapy for IBD
- Vedolizumab Therapy Group: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
- Group B: Systemic immunosuppressive Group at least 75 participants
- Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
- Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
- Anti-TNF Combination Therapy 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
- Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
- Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
- Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
- Participant has been on the same IBD treatment for at least two months.
- Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by their clinical provider or has started the COVID-19 series or finished the mRNA COVID-19 vaccine series within the past six months and would qualify for six month study visits or has received a third dose of the vaccine as standard of care.
- Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
- For Viral vector cohort:
- Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- On one of the following treatment regimens:
- Group A: Non-systemic immunosuppressive Group at least 15 participants
- Mesalamine monotherapy or no therapy for IBD
- Vedolizumab Therapy Group: on vedolizumab monotherapy
- Group B: Systemic immunosuppressive Group at least 15 participants
- Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
- Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
- Anti-TNF Combination Therapy 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
- Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
- Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
- Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
- Participant has been on the same IBD treatment for at least two months.
- Participant is receiving a viral vector COVID-19 vaccine per standard of care or has started or finished the viral vector series within the past 6 months. If participant entering at six months and would qualify for six month study visits and has received an additional one or two dose of viral vector of mRNA for a total of two -three COVID vaccines as standard of care.
- Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
Exclusion
- For mRNA cohort:
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
- For Viral vector cohort:
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent.
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Key Trial Info
Start Date :
March 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04818892
Start Date
March 26 2021
End Date
November 11 2022
Last Update
December 7 2022
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705