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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05014555
• Other study ID #: CNTO1275IBD4005
• Status: Not yet recruiting
• Start date: July 5, 2023
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: GI Alliance
• Contact: Melinda Dollar
• Phone: 4699303107
• Email: melinda.dollar[@]gialliance.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care

Locations

Country	Name	City	State
United States	GI Alliance	Baton Rouge	Louisiana
United States	Mayo Clinic Jacksonville, FL	Jacksonville	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	GI Alliance	Southlake	Texas

Sponsors (4)

Lead Sponsor	Collaborator
GI Alliance	Janssen, LP, Mayo Clinic, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sustained cell-mediated immunity against Covid-spike proteins will be evaluated using IFN-? ELISpot, which detects both CD4 and CD8 T cell effectors.	Evaluation of sustained cell mediated immunity against Covid-spike proteins. IFN-? 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
Secondary	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
Secondary	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