IBDNCT04818892
Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
An observational study of IBD and Covid19 Vaccine, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- IBD, Covid19 Vaccine
- What is being tested?
- Serological Assay for SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 11 Nov 2022
- 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: Participants with IBD and scheduled to receive a COVID-19 vaccine will be recruited from the University of Wisconsin Hospital and Clinics if they meet the inclusion and exclusion criteria. * Group A IBD patients on non-systemic immunosuppressive therapy: no therapy or aminosalicylates or vedolizumab therapy * Group B IBD patients on systemic immunosuppression Patients in both groups will have been on stable treatment for IBD for at least two months.
Who may be able to join
- For mRNA cohort:
- Participant 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:
- Group A: Non-systemic immunosuppressive Group at least 75 participants
- Mesalamine monotherapy or no therapy for IBD
- Vedolizumab Therapy Group: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
Show all 32Show fewer
- Group B: Systemic immunosuppressive Group at least 75 participants
- Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
- Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
- 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
- Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
- Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
- Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
- Participant has been on the same IBD treatment for at least two months.
- Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by their clinical provider or has started the COVID-19 series or finished the mRNA COVID-19 vaccine series within the past six months and would qualify for six month study visits or has received a third dose of the vaccine as standard of care.
- Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
- For Viral vector cohort:
- Participant 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:
- Group A: Non-systemic immunosuppressive Group at least 15 participants
- Mesalamine monotherapy or no therapy for IBD
- Vedolizumab Therapy Group: on vedolizumab monotherapy
- Group B: Systemic immunosuppressive Group at least 15 participants
- Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
- Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
- 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
- Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
- Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
- Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
- Participant has been on the same IBD treatment for at least two months.
- Participant is receiving a viral vector COVID-19 vaccine per standard of care or has started or finished the viral vector series within the past 6 months. If participant entering at six months and would qualify for six month study visits and has received an additional one or two dose of viral vector of mRNA for a total of two -three COVID vaccines as standard of care.
- Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
Who cannot join
- For mRNA cohort:
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
- For Viral vector cohort:
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent.
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may need more doses of a vaccine, with future adjuvanted vaccines or require a booster to maintain immunity. 260 participants with IBD and scheduled to get a COVID-19 vaccine will be recruited and can expect to be on study for 18 months.
Read the detailed description
COVID-19 has a variable spectrum of illness with the majority of infection resulting in asymptomatic or mild disease. However certain healthy adults and immunosuppressed populations can develop severe or critical symptoms that require hospitalization or intensive care stay. Emerging evidence suggest that certain immunosuppressive medications used to treat patients with IBD such as anti-tumor necrosis factor (TNF) do not appear to confer an increased risk for severe COVID-19, but the risk appears to be higher for other agents such as corticosteroids. The efficacy of a candidate COVID-19 may be lower in immunosuppressed patients with IBD, since these patient populations may have lower responses to vaccines. Multiple studies have shown that patients with IBD have variability in their vaccine responses compared to healthy individuals. While many patients have a normal vaccine response, those treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are more likely to mount a poor immune response. Furthermore, preliminary data suggest some novel regimens (such as vedolizumab) may not impact the immune response but there is insufficient data to know their impact on vaccine response. Thus, there is a critical need to determine whether patients with IBD will mount normal immune responses to a COVID-19 vaccine.
This is a single center cross sectional clinical study of 260 patients with IBD who are receiving the COVID-19 vaccine as standard of care. After obtaining informed consent, individuals who meet the inclusion criteria and none of the exclusion criteria will be invited to participate in the study.
Aim 1. Determine the immunogenicity and safety of a COVID-19 vaccine in patients with IBD. To achieve this aim, the investigators will perform a prospective study evaluating the immunogenicity of a COVID-19 vaccine in 260 patients with IBD.
- Hypothesis: Systemic immunosuppressive regimens such as Anti-TNF in combination with an immunomodulator, associated with the lowest vaccine response, or other systemic immunosuppressive regimens will blunt the immunogenicity of a COVID-19 vaccine while other agents such as vedolizumab or aminosalicylates will not affect the vaccine response.
Aim 2. Determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received the COVID-19 vaccine. To achieve this aim, the investigators will evaluate sustained antibody concentrations using a quantitative assay from LabCorp that is currently being used by the Centers for Disease Control and Prevention (CDC) to evaluate seroprevalence and study immunity at 1, 6, 12, and 18 months after completion of vaccination. Labcorp activities are provided as a fee for service. Follow up In-Person visit 1 (one month visit) will be optional and participants can enter the study at the six months study visit (Follow up In-Person visit 2) or at approximately 1-2 month post third dose of the COVID-19 vaccine which has been approved for patients with IBD. The 12 month visit (Follow up In-Person visit 3) may be replaced by a 6 month post 3rd dose vaccine if participants received one booster, or1-2 months post a 4th dose vaccine if participants received a second booster. The 18 month visit (Follow up In-Person visit 4) may substitute for a 12, 6, or 1-2 months post vaccine, depending on when and how many boosters the participant received.
- Hypothesis: Vaccine-induced antibody concentrations will wane over the 12 month interval faster than the published rate in healthcare workers.
At the completion of the proposed research, the safety and immunogenicity of a COVID-19 vaccine in immunosuppressed patients with IBD will be determined.
Protocol Amendment Approved 2/24/2022 changes time points of data collection to 18 months post-2nd dose, 9 month post-3rd dose, or 3-4 months post-4th dose.
Protocol Amendment Approved 4/19/2022 changes time points of data collection to 18 months post-2nd dose, 12 month post-3rd dose, or 6 months post-4th dose.
Protocol Amendment Approved 6/21/2022 indicates that follow up In-Person Visit 4 (will occur from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can occur at any time after completion of any doses of a COVID-19 vaccine series). For participants who have not completed Visit 3 prior to July 2022, Visit 3 will be their last blood draw, which can occur from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can occur at any time after completion of any doses of a COVID-19 vaccine series).
- Conditions
- IBD, Covid19 Vaccine
- Being tested
- Serological Assay for SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological Assay for SARS-CoV-2Diagnostic test
LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
| Study group | Role | What they receive |
|---|---|---|
| IBD and Non-Immunosuppressive Group | Clinical diagnosis of IBD, non-systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19 Receives: Diagnostic Test: Serological Assay for SARS-CoV-2 | |
| IBD and Immunosuppressive Group | Clinical diagnosis of IBD, treated with systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19 Receives: Diagnostic Test: Serological Assay for SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series
The primary endpoint will be evaluating the change in humoral immunity between the immunosuppressive and non-immunosuppressive IBD treatment regimens following the recommended doses mRNA COVID-19 vaccine series.
Measured: baseline to 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Sustained antibody concentrations of mRNA COVID-19 vaccines
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Measured: 18 months post-2nd dose
Sustained antibody concentrations of mRNA COVID-19 vaccines
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Measured: 12 months post-3rd dose
Sustained antibody concentrations of mRNA COVID-19 vaccines
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Measured: 6 months post-4th dose
Change in level of T-cell response after mRNA COVID-19 vaccine
Investigators will evaluate sustained cell mediated immunity against Covid-spike proteins after completing the vaccine schedule of a mRNA COVID-19 vaccine.
Measured: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Percentage of participants with detectable level of T-cell response after mRNA COVID-19 vaccine
For each patient, peripheral blood monocytes (PBMCs) will be isolated. 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. The plates will be read on an AID ELISpot reader (Cell Technology, Inc., Columbia MD, reader software v.3.1.1.). A positive response to antigen will be defined as a frequency that was significantly (p < 0.05, two-tailed t test) greater than the mean of control no-antigen wells and detectable (i.e., >1:100,000). T cell responses will be correlated to Covid-19 neutralizing antibody responses.
Measured: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Secondary outcomes (9)
Incidence of Adverse Events
Safety will be assessed by the incidence of adverse events (AEs and SAEs) related to the vaccine.
Measured: up to 1 month post final immunization
Patient reported outcome 3 (PRO3) score
Safety will be assessed by monitoring the PRO3 scores at baseline and 1 month post-vaccination. PRO-3 is a measure of overall well-being as well as specific symptoms and complications of CD, such as stool frequency, abdominal pain and general well being. Greater PRO3 scores indicate more severe CD symptoms.
Measured: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Simple Colitis Activity Index (SCAI) Questionnaire Score
For participants with Ulcerative Colitis (UC), safety will be assessed by monitoring the SCAI score at baseline and 1 month post-vaccination. SCAI is a measure of overall well-being as well as specific symptoms and complications of UC, such as stool frequency and abdominal pain. The total possible range of scores is 0-21, with higher scores indicative of increased symptoms.
Measured: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Seroconversion: assessed by percentages of participants with ≥4-fold rise in antibody titer
Percentages (and 2-sided 95% CIs) of participants with ≥4-fold rise will be assessed for the COVID-19 vaccine within each group.
Measured: 1 month post-immunization
Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following two doses of viral vector COVID-19 vaccine series
The primary endpoint will be evaluating the change in humoral immunity between the immunosuppressive and non-immunosuppressive IBD treatment regimens following the two doses viral vector COVID-19 vaccine series.
Measured: baseline,18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Sustained antibody concentration of viral vector COVID-19 vaccines
The investigators will evaluate sustained antibody concentrations of viral vector COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Measured: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Percentage of participants with detectable level of T-cell response after viral vector COVID-19 vaccine
For each patient, peripheral blood monocytes (PBMCs) will be isolated. 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. The plates will be read on an AID ELISpot reader (Cell Technology, Inc., Columbia MD, reader software v.3.1.1.). A positive response to antigen will be defined as a frequency that was significantly (p < 0.05, two-tailed t test) greater than the mean of control no-antigen wells and detectable (i.e., >1:100,000). T cell responses will be correlated to Covid-19 neutralizing antibody responses.
Measured: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Change in level of T-cell response after viral vector COVID-19 vaccine
Investigators will evaluate sustained cell mediated immunity against Covid-spike protein after completing the vaccine schedule of a viral vectors vaccine.
Measured: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Presence of SARS-CoV2 anti-nucleocapside antibody : Yes/No
To evaluate the rate of asymptomatic COVID-19 infections in patients with IBD, investigators will evaluate the presence for anti-nucleocapside antibody in participants at baseline and/or 1 month visit after immunization to evaluate the rate of asymptomatic infection in our cohort. A SARS-CoV2 anti-nucleocapside antibody is not induced by vaccine so it's presence means there was a presence of a previous infection.
Measured: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start26 Mar 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, MS, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818892
- Sponsor's protocol ID
- 2021-0043
- Other IDs
- A534250, SMPH/MEDICINE/GASTROENT, Protocol Version 6/6/2022, MSN252947, MSN253788
- Status last verified
- Dec 2022
- First submitted
- 25 Mar 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04818892
- Acronym / sponsor ID
- 2021-0043
- Conditions
- IBD, Covid19 Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 26 Mar 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 overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may need more doses of a vaccine, with future adjuvanted vaccines or require a booster to maintain immunity. 260 participants with IBD and scheduled to get a COVID-19 vaccine will be recruited and can expect to be on study for 18 months.
Detailed description
COVID-19 has a variable spectrum of illness with the majority of infection resulting in asymptomatic or mild disease. However certain healthy adults and immunosuppressed populations can develop severe or critical symptoms that require hospitalization or intensive care stay. Emerging evidence suggest that certain immunosuppressive medications used to treat patients with IBD such as anti-tumor necrosis factor (TNF) do not appear to confer an increased risk for severe COVID-19, but the risk appears to be higher for other agents such as corticosteroids. The efficacy of a candidate COVID-19 may be lower in immunosuppressed patients with IBD, since these patient populations may have lower responses to vaccines. Multiple studies have shown that patients with IBD have variability in their vaccine responses compared to healthy individuals. While many patients have a normal vaccine response, those treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are more likely to mount a poor immune response. Furthermore, preliminary data suggest some novel regimens (such as vedolizumab) may not impact the immune response but there is insufficient data to know their impact on vaccine response. Thus, there is a critical need to determine whether patients with IBD will mount normal immune responses to a COVID-19 vaccine.
This is a single center cross sectional clinical study of 260 patients with IBD who are receiving the COVID-19 vaccine as standard of care. After obtaining informed consent, individuals who meet the inclusion criteria and none of the exclusion criteria will be invited to participate in the study.
Aim 1. Determine the immunogenicity and safety of a COVID-19 vaccine in patients with IBD. To achieve this aim, the investigators will perform a prospective study evaluating the immunogenicity of a COVID-19 vaccine in 260 patients with IBD.
- Hypothesis: Systemic immunosuppressive regimens such as Anti-TNF in combination with an immunomodulator, associated with the lowest vaccine response, or other systemic immunosuppressive regimens will blunt the immunogenicity of a COVID-19 vaccine while other agents such as vedolizumab or aminosalicylates will not affect the vaccine response.
Aim 2. Determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received the COVID-19 vaccine. To achieve this aim, the investigators will evaluate sustained antibody concentrations using a quantitative assay from LabCorp that is currently being used by the Centers for Disease Control and Prevention (CDC) to evaluate seroprevalence and study immunity at 1, 6, 12, and 18 months after completion of vaccination. Labcorp activities are provided as a fee for service. Follow up In-Person visit 1 (one month visit) will be optional and participants can enter the study at the six months study visit (Follow up In-Person visit 2) or at approximately 1-2 month post third dose of the COVID-19 vaccine which has been approved for patients with IBD. The 12 month visit (Follow up In-Person visit 3) may be replaced by a 6 month post 3rd dose vaccine if participants received one booster, or1-2 months post a 4th dose vaccine if participants received a second booster. The 18 month visit (Follow up In-Person visit 4) may substitute for a 12, 6, or 1-2 months post vaccine, depending on when and how many boosters the participant received.
- Hypothesis: Vaccine-induced antibody concentrations will wane over the 12 month interval faster than the published rate in healthcare workers.
At the completion of the proposed research, the safety and immunogenicity of a COVID-19 vaccine in immunosuppressed patients with IBD will be determined.
Protocol Amendment Approved 2/24/2022 changes time points of data collection to 18 months post-2nd dose, 9 month post-3rd dose, or 3-4 months post-4th dose.
Protocol Amendment Approved 4/19/2022 changes time points of data collection to 18 months post-2nd dose, 12 month post-3rd dose, or 6 months post-4th dose.
Protocol Amendment Approved 6/21/2022 indicates that follow up In-Person Visit 4 (will occur from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can occur at any time after completion of any doses of a COVID-19 vaccine series). For participants who have not completed Visit 3 prior to July 2022, Visit 3 will be their last blood draw, which can occur from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can occur at any time after completion of any doses of a COVID-19 vaccine series).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD and Non-Immunosuppressive Group | – | Diagnostic Test: Serological Assay for SARS-CoV-2Clinical diagnosis of IBD, non-systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19 |
| IBD and Immunosuppressive Group | – | Diagnostic Test: Serological Assay for SARS-CoV-2Clinical diagnosis of IBD, treated with systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with IBD and scheduled to receive a COVID-19 vaccine will be recruited from the University of Wisconsin Hospital and Clinics if they meet the inclusion and exclusion criteria. * Group A IBD patients on non-systemic immunosuppressive therapy: no therapy or aminosalicylates or vedolizumab therapy * Group B IBD patients on systemic immunosuppression Patients in both groups will have been on stable treatment for IBD for at least two months.
Key inclusion criteria (32 listed)
- Participant 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:
- Participant has been on the same IBD treatment for at least two months.
- Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by their clinical provider or has started the COVID-19 series or finished the mRNA COVID-19 vaccine series within the past six months and would qualify for six month study visits or has received a third dose of the vaccine as standard of care.
- Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
Key exclusion criteria (8 listed)
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
- Allergy to COVID-19 vaccine or a component of it
- Participant cannot or will not provide written informed consent.
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 |
|---|---|---|
| Serological Assay for SARS-CoV-2LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2. | Diagnostic test | IBD and Immunosuppressive Group, IBD and Non-Immunosuppressive Group |
Primary outcome
Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series
Time frame: baseline to 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
The primary endpoint will be evaluating the change in humoral immunity between the immunosuppressive and non-immunosuppressive IBD treatment regimens following the recommended doses mRNA COVID-19 vaccine series.
Sustained antibody concentrations of mRNA COVID-19 vaccines
Time frame: 18 months post-2nd dose
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Sustained antibody concentrations of mRNA COVID-19 vaccines
Time frame: 12 months post-3rd dose
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Sustained antibody concentrations of mRNA COVID-19 vaccines
Time frame: 6 months post-4th dose
The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.
Change in level of T-cell response after mRNA COVID-19 vaccine
Time frame: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Investigators will evaluate sustained cell mediated immunity against Covid-spike proteins after completing the vaccine schedule of a mRNA COVID-19 vaccine.
Percentage of participants with detectable level of T-cell response after mRNA COVID-19 vaccine
Time frame: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
For each patient, peripheral blood monocytes (PBMCs) will be isolated. 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. The plates will be read on an AID ELISpot reader (Cell Technology, Inc., Columbia MD, reader software v.3.1.1.). A positive response to antigen will be defined as a frequency that was significantly (p < 0.05, two-tailed t test) greater than the mean of control no-antigen wells and detectable (i.e., >1:100,000). T cell responses will be correlated to Covid-19 neutralizing antibody responses.
9 secondary outcomes
Incidence of Adverse Events
Time frame: up to 1 month post final immunization
Patient reported outcome 3 (PRO3) score
Time frame: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Simple Colitis Activity Index (SCAI) Questionnaire Score
Time frame: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Seroconversion: assessed by percentages of participants with ≥4-fold rise in antibody titer
Time frame: 1 month post-immunization
Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following two doses of viral vector COVID-19 vaccine series
Time frame: baseline,18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Sustained antibody concentration of viral vector COVID-19 vaccines
Time frame: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Percentage of participants with detectable level of T-cell response after viral vector COVID-19 vaccine
Time frame: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Change in level of T-cell response after viral vector COVID-19 vaccine
Time frame: 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Presence of SARS-CoV2 anti-nucleocapside antibody : Yes/No
Time frame: baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Freddy Caldera, DO, MS principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Covid19 Vaccine, run by University of Wisconsin, Madison at 1 site 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?
The sponsor lists 32 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series (time frame: baseline to 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose). The study lists 6 primary outcomes in all. 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 7 Dec 2022.