History of Changes for Study: NCT05014555

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			August 18, 2021	None (earliest Version on record)
2			June 14, 2023	Contacts/Locations, Study Status, Outcome Measures, Eligibility and Groups and Interventions

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CNTO1275IBD4005
Brief Title:	Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
Official Title:	Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
Secondary IDs:

Study Status


Record Verification:	August 2021
Overall Status:	Not yet recruiting
Study Start:	August 2021
Primary Completion:	May 2022 [Anticipated]
Study Completion:	May 2022 [Anticipated]

First Submitted:	August 13, 2021
First Submitted that Met QC Criteria:	August 18, 2021
First Posted:	August 20, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	August 18, 2021
Last Update Posted:	August 20, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	GI Alliance
Responsible Party:	Sponsor
Collaborators:	Janssen, LP University of Wisconsin, Madison Mayo Clinic

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


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:

Conditions


Conditions:	Inflammatory Bowel Diseases
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Cross-Sectional
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	whole blood
Enrollment:	400 [Anticipated]
Number of Groups/Cohorts	4

Groups and Interventions

Groups/Cohorts	Interventions
Group A Non-biologic Group Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.	Biological: COVID-19 Vaccine Two-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 Two-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 Two-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 Two-dose mRNA COVID-19 vaccine per standard of care

Outcome Measures


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 second 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 by measuring geometric mean titers (GMT) of SARS-CoV-2 antibody concentrations at 6 and 12 months after the 2nd dose of the vaccine in patients with IB. 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: 6 and 12 months after second dose of the COVID-19 vaccine ] 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: 6 and 12 months after second dose of the COVID-19 vaccine ] 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: 6 and 12 months after second dose of the COVID-19 vaccine ] The NIH ELISA assay will be used to evaluate change in S and RBD (IgG and IgM) antibody titers.

Eligibility


Study Population:	Inflammatory bowel disease patients, Gastroenterology practice
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:	85 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion 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, golilumab within the previous 4 weeks, adalilumab 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 a two-dose mRNA COVID-19 vaccine per standard of care Exclusion Criteria: Previous COVID-19 infection 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.

Contacts/Locations


Central Contact Person:	Lauri Befus Telephone: 214-924-5996 Email: Lauri.Befus@gialliance.com
Central Contact Backup:	Jackie Ward Telephone: 817-310-4421 Email: Jacklyn.Ward@gialliance.com
Study Officials:	Tim Ritter, MD Principal Investigator GI Alliance
Locations:	United States, Florida
	Mayo Clinic Jacksonville, FL Jacksonville, Florida, United States, 32224 Contact:Principal Investigator: Francis A Farraye, MD
	United States, Louisiana
	GI Alliance Baton Rouge, Louisiana, United States, 70809 Contact:Contact: Lauri Befus 214-924-5996 Lauri.Befus@gialliance.com Contact:Contact: Dana Reed-Alexander 225-927-1190 Ext. 7850 Dana.Reed-alexander@gialliance.com
	United States, Texas
	GI Alliance Cedar Park, Texas, United States, 78613 Contact:Contact: Lauri Befus 214-924-5996 Lauri.Befus@gialliance.com Contact:Contact: Jocelyn Largent 512-861-3596 Ext. 6088 jocelyn.largent@gialliance.com
	GI Alliance Southlake, Texas, United States, 76092 Contact:Contact: Lauri Befus 214-924-5996 Lauri.Befus@gialliance.com Contact:Contact: Weam Ali 832-618-6852 Weam.Ali@gialliance.com
	United States, Wisconsin
	University of Wisconsin Madison, Wisconsin, United States, 53726 Contact:Principal Investigator: Freddy Caldera, DO

IPDSharing


Plan to Share IPD:	Yes All IPD that underlie results in a publication
	Supporting Information: 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.
	URL:

References


Citations:
Links:
Available IPD/Information: