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

A patient will be eligible for inclusion in this study if he or she meets all the following
criteria:

- Patient is between the ages of 18-85 years, inclusive

- Patient 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 for at least three months at the time of
immunization and continued same therapy at the time of recruitment. Should be on
stable doses defined as: Group A should have taken a dose of medication within the
past week; Group B infliximab within the previous 8 weeks, golimumab within the
previous 4 weeks, adalimumab within the previous 2 weeks, or certolizumab within the
previous 4 weeks; Those on combination therapy in group B will have taken azathioprine
or methotrexate within the past week. Group C ustekinumab at least within the previous
4 weeks. Those on combination therapy in group C will have taken azathioprine or
methotrexate within the past week; Group D vedolizumab at least within the previous 4
weeks. Those on combination therapy in group D will have taken azathioprine or
methotrexate within the past week

- Group A non-biologic group: mesalamine monotherapy or thiopurine monotherapy

- Group B: Anti-TNF Therapy Group: on maintenance therapy infliximab (at least
5mg/kg every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2
weeks), or certolizumab (at least monthly Combination Therapy 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 at
least 40% of the group; Approximately 40-50% of the group will be combination
therapy

- 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

- Patient received at least two doses of mRNA COVID-19 vaccine per standard of care

A patient will not be eligible for inclusion in this study if he or she meets all the
following criteria:

- Patient cannot or will not provide written informed consent

- Unable to provide appropriate informed consent due to being illiterate or impairment
in decision-making capacity

- Received a COVID-19 booster within the previous 28 days