Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT04818892
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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).
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: