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

Not yet recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT05014555
• Lead Sponsor: GI Alliance

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18
• Study Start: 2023-07-05
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B Anti-TNF Group	COVID-19 Vaccine	Participants on treatment regimen of maintenance montherapy of infliximab (at least 8 every 8 weeks), golilumamb (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly), or combination therapy of anti-TNF therapy as described above along with either 15mg of methotrexate or azathiprine at least 1.0mg/kg or 6MP 0.5mg/kg.
Group C Ustekinumab Group	COVID-19 Vaccine	Participants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
Group A Non-biologic Group	COVID-19 Vaccine	Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.
Group D Vedolizumab Group	COVID-19 Vaccine	Participants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.

Primary Outcome Measures

Name	Time	Method
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	6 and 12 months after third dose of the COVID-19 vaccine, with primary outcome being sustained antibody concentrations at 12 months	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.

Secondary Outcome Measures

Name	Time	Method
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 booster	Evaluation of the persistence of memory B cell in approximately one-third of participants.
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 booster	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.
Sustained antibody concentration evaluating spike protein and receptor binding	during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster	The NIH ELISA assay will be used to evaluate change in S and RBD (IgG and IgM) antibody titers.

Trial Locations

Locations (3)

Mayo Clinic Jacksonville, FL; 🇺🇸 Jacksonville, Florida, United States

GI Alliance; 🇺🇸 Southlake, Texas, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States