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

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 Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Biological: COVID-19 Vaccine

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Melinda Dollar; Phone Number: 4699303107; Email: melinda.dollar@gialliance.com
• Study Contact Backup: Name: Jo Ann Gilbert; Phone Number: 9726378546; Email: joann.gilbert@gialliance.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville, FL
      • Principal Investigator: Francis A Farraye, MD
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • GI Alliance
      • Contact: Dana Reed-Alexander; Phone Number: 7805 225-927-1190; Email: dana.reed-alexander@gialliance.com
      • Contact: Celestial Reed; Phone Number: 8734 225-927-1190; Email: celestial.reed@gialliance.com
  • Texas
    • Southlake, Texas, United States, 76092
      • GI Alliance
      • Contact: Andrew Black; Phone Number: 817-562-0039; Email: andrew.black@gialliance.com
      • Contact: Prince Ayalogu; Phone Number: 817-612-5537; Email: prince.ayalogu@gialliance.com
  • Wisconsin
    • Madison, Wisconsin, United States, 53726
      • University of Wisconsin
      • Principal Investigator: Freddy Caldera, DO
      • Contact: Freddy Caldera, DO; Email: fcaldera@medicine.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients, Gastroenterology practice

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A Non-biologic Group; Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.	Biological: COVID-19 Vaccine; Three-dose mRNA COVID-19 vaccine per standard of care
Group B Anti-TNF Group; 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.	Biological: COVID-19 Vaccine; Three-dose mRNA COVID-19 vaccine per standard of care
Group C Ustekinumab Group; Participants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.	Biological: COVID-19 Vaccine; Three-dose mRNA COVID-19 vaccine per standard of care
Group D Vedolizumab Group; Participants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.	Biological: COVID-19 Vaccine; Three-dose mRNA COVID-19 vaccine per standard of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster

Collaborators and Investigators

• Sponsor: GI Alliance
• Collaborators: Mayo Clinic; University of Wisconsin, Madison; Janssen, LP
• Investigators: Principal Investigator: Tim Ritter, MD, GI Alliance

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: CNTO1275IBD4005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Immediately following publication.
• IPD Sharing Access Criteria: With researchers who provide a methodically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to Tim.Ritter@GIAlliance.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No