Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT05067959
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.
Detailed Description:
Overall Aims:
1. To assess the immune response to COVID-19 vaccination in patients with IBD.
2. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
3. To evaluate the different variables affecting immunity of these patients.
4. To assess adverse reactions to COVID-19 vaccines and IBD related complications.
Specifically:
1. To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
1. Healthy controls
2. Patients with IBD not treated with anti-TNF (+/- immunomodulators)
2. To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
3. To identify factors associated with serologic response
4. Side effects to vaccines
5. IBD exacerbation compared to activity at baseline
6. Symptomatic COVID-19
1. To assess the immune response to COVID-19 vaccination in patients with IBD.
2. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
3. To evaluate the different variables affecting immunity of these patients.
4. To assess adverse reactions to COVID-19 vaccines and IBD related complications.
Specifically:
1. To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
1. Healthy controls
2. Patients with IBD not treated with anti-TNF (+/- immunomodulators)
2. To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
3. To identify factors associated with serologic response
4. Side effects to vaccines
5. IBD exacerbation compared to activity at baseline
6. Symptomatic COVID-19
Study Oversight
Has Oversight DMC:
False
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?: