Inflammatory Bowel DiseasesNCT05014555
Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by GI Alliance at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jul 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
GI Alliance
Baton Rouge, Louisiana, 70809
Dana Reed-Alexander, 225-927-1190 ext. 7805, dana.reed-alexander@gialliance.com
Celestial Reed, 225-927-1190 ext. 8734, celestial.reed@gialliance.com
Mayo Clinic Jacksonville, FL
Jacksonville, Florida, 32224
Francis A Farraye, MD
University of Wisconsin
Madison, Wisconsin, 53726
Freddy Caldera, DO, fcaldera@medicine.wisc.edu
Freddy Caldera, DO
GI Alliance
Southlake, Texas, 76092
Andrew Black, 817-562-0039, andrew.black@gialliance.com
Prince Ayalogu, 817-612-5537, prince.ayalogu@gialliance.com
About this study
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
- Being tested
- COVID-19 Vaccine
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Three-dose mRNA COVID-19 vaccine per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group A Non-biologic Group | Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids. Receives: 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. Receives: Biological: COVID-19 Vaccine | |
| Group C Ustekinumab Group | Participants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine. Receives: Biological: COVID-19 Vaccine | |
| Group D Vedolizumab Group | Participants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start5 Jul 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, University of Wisconsin, Madison, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Tim Ritter, MD, Principal investigator, GI Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014555
- Sponsor's protocol ID
- CNTO1275IBD4005
- Status last verified
- Jun 2023
- First submitted
- 13 Aug 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05014555
- Acronym / sponsor ID
- CNTO1275IBD4005
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GI AllianceUniversity, hospital or other
- Collaborators
- Janssen, LP, University of Wisconsin, Madison, Mayo Clinic
- Study start
- 5 Jul 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A Non-biologic Group | – | Biological: COVID-19 VaccineParticipants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids. |
| Group B Anti-TNF Group | – | Biological: COVID-19 VaccineParticipants 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. |
| Group C Ustekinumab Group | – | Biological: COVID-19 VaccineParticipants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine. |
| Group D Vedolizumab Group | – | Biological: COVID-19 VaccineParticipants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory bowel disease patients, Gastroenterology practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineThree-dose mRNA COVID-19 vaccine per standard of care | Biological | Group A Non-biologic Group, Group B Anti-TNF Group, Group C Ustekinumab Group, Group D Vedolizumab Group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Ritter, MD principal investigator
GI Alliance
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by GI Alliance at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melinda Dollar (4699303107, melinda.dollar@gialliance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.