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.
Study Type
OBSERVATIONAL
Enrollment
400
Three-dose mRNA COVID-19 vaccine per standard of care
Mayo Clinic Jacksonville, FL
Jacksonville, Florida, United States
GI Alliance
Baton Rouge, Louisiana, United States
GI Alliance
Southlake, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
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 levels
Evaluation 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.
Time frame: 6 and 12 months after third dose of the COVID-19 vaccine, with primary outcome being sustained antibody concentrations at 12 months
Sustained cell-mediated immunity against Covid-spike proteins will be evaluated using IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors.
Evaluation 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.
Time frame: during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster
Evaluate the persistence of memory B cell using memory B cell analysis.
Evaluation of the persistence of memory B cell in approximately one-third of participants.
Time frame: during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster
Sustained antibody concentration evaluating spike protein and receptor binding
The NIH ELISA assay will be used to evaluate change in S and RBD (IgG and IgM) antibody titers.
Time frame: during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster
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