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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014555
Recruitment Status : Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : June 18, 2023
Sponsor:
Collaborators:
Janssen, LP
University of Wisconsin, Madison
Mayo Clinic
Information provided by (Responsible Party):
GI Alliance

Study Description
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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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Biological: COVID-19 Vaccine

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
Estimated Study Start Date : July 5, 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. Sustained cell-mediated immunity against Covid-spike proteins will be evaluated using IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors. [ Time Frame: 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.

  2. Evaluate the persistence of memory B cell using memory B cell analysis. [ Time Frame: 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.

  3. Sustained antibody concentration evaluating spike protein and receptor binding [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inflammatory bowel disease patients, Gastroenterology practice
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014555


Contacts
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Contact: Melinda Dollar 4699303107 melinda.dollar@gialliance.com
Contact: Jo Ann Gilbert 9726378546 joann.gilbert@gialliance.com

Locations
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United States, Florida
Mayo Clinic Jacksonville, FL
Jacksonville, Florida, United States, 32224
Principal Investigator: Francis A Farraye, MD         
United States, Louisiana
GI Alliance
Baton Rouge, Louisiana, United States, 70809
Contact: Dana Reed-Alexander    225-927-1190 ext 7805    dana.reed-alexander@gialliance.com   
Contact: Celestial Reed    225-927-1190 ext 8734    celestial.reed@gialliance.com   
United States, Texas
GI Alliance
Southlake, Texas, United States, 76092
Contact: Andrew Black    817-562-0039    andrew.black@gialliance.com   
Contact: Prince Ayalogu    817-612-5537    prince.ayalogu@gialliance.com   
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53726
Contact: Freddy Caldera, DO       fcaldera@medicine.wisc.edu   
Principal Investigator: Freddy Caldera, DO         
Sponsors and Collaborators
GI Alliance
Janssen, LP
University of Wisconsin, Madison
Mayo Clinic
Investigators
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Principal Investigator: Tim Ritter, MD GI Alliance
More Information
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Responsible Party: GI Alliance
ClinicalTrials.gov Identifier: NCT05014555    
Other Study ID Numbers: CNTO1275IBD4005
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis