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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05014555
Enrollment
400
Registered
2021-08-20
Start date
2023-07-05
Completion date
2024-01-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Brief summary

The aim of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19 vaccine.

Interventions

BIOLOGICALCOVID-19 Vaccine

Three-dose mRNA COVID-19 vaccine per standard of care

Sponsors

Janssen, LP
CollaboratorINDUSTRY
University of Wisconsin, Madison
CollaboratorOTHER
Mayo Clinic
CollaboratorOTHER
GI Alliance
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the immunogenicity of the COVID-19 vaccines by measuring geometric mean titers (GMT) of SARS-CoV-2 antibody concentrations, and quantitative assays to evaluate RBD-binding IgG levels6 and 12 months after third dose of the COVID-19 vaccine, with primary outcome being sustained antibody concentrations at 12 monthsEvaluation of the immunogenicity of the COVID-19 vaccines prior to patients receiving a COVID-19 booster during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster. Quantitative assays will be used to evaluate RBD-binding IgG levels.

Secondary

MeasureTime frameDescription
Sustained cell-mediated immunity against Covid-spike proteins will be evaluated using IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors.during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 boosterEvaluation of sustained cell mediated immunity against Covid-spike proteins. IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors, will be used to detect T-cell immunity to the Covid-spike protein or peptides.
Evaluate the persistence of memory B cell using memory B cell analysis.during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 boosterEvaluation of the persistence of memory B cell in approximately one-third of participants.
Sustained antibody concentration evaluating spike protein and receptor bindingduring the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 boosterThe NIH ELISA assay will be used to evaluate change in S and RBD (IgG and IgM) antibody titers.

Countries

United States

Contacts

Primary ContactMelinda Dollar
melinda.dollar@gialliance.com4699303107
Backup ContactJo Ann Gilbert
joann.gilbert@gialliance.com9726378546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026