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

NCT05014555 | Unknown

• 1 other identifier: CNTO1275IBD4005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

Group A Non-biologic Group

Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.

Biological: COVID-19 Vaccine

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

Group C Ustekinumab Group

Participants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.

Biological: COVID-19 Vaccine

Group D Vedolizumab Group

Participants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.

Biological: COVID-19 Vaccine

Interventions

COVID-19 Vaccine BIOLOGICAL

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

Group A Non-biologic Group; Group B Anti-TNF Group; Group C Ustekinumab Group; Group D Vedolizumab Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients, Gastroenterology practice

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GI Alliance: lead
• Janssen, LP: collaborator
• University of Wisconsin, Madison: collaborator
• Mayo Clinic: collaborator

Study Sites (4)

Mayo Clinic Jacksonville, FL

Jacksonville, Florida, 32224, United States

Location

GI Alliance

Baton Rouge, Louisiana, 70809, United States

Location

GI Alliance

Southlake, Texas, 76092, United States

Location

University of Wisconsin

Madison, Wisconsin, 53726, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Tim Ritter, MD

  GI Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Dollar

CONTACT

4699303107; melinda.dollar@gialliance.com

Jo Ann Gilbert

CONTACT

9726378546; joann.gilbert@gialliance.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: July 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately following publication.
• 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.

Locations

US (4)