Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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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
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Overall Aims: To assess the immune response to COVID-19 vaccination in patients with IBD. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies. To evaluate the different variables affecting immunity of these patients. To assess adverse reactions to COVID-19 vaccines and IBD related complications. Specifically: To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to Healthy controls Patients with IBD not treated with anti-TNF (+/- immunomodulators) To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD To identify factors associated with serologic response Side effects to vaccines IBD exacerbation compared to activity at baseline Symptomatic COVID-19

Official Title
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Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Conditions
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IBD, Covid19

Intervention / Treatment
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* Biological: Covid-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Adults >18 years of age 2. Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 [i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection 4. Ability to attend follow up visits 5. Ability to understand and sign an informed consent form Exclusion Criteria: 1. Pregnant women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBD patients<br>patients with IBD (Chron's disease, Ulcerative colitis, IBD-Unspecify). patients will be divided into two sub-groups: IBD patients on anti-TNF therapy IBD patients on any other therapy | Biological: Covid-19 vaccine<br>* blood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine<br>|
| Controls<br>healthy volunteers | Biological: Covid-19 vaccine<br>* blood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccine efficacy in IBD population | • Efficacy of the vaccination for IBD patients compared to the normal population measured as proportion of patients achieving positive serology | 4 weeks post second COVID-19 vaccine. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease related variant affect immunological response | Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine | 12 months | 
| Therapy related variants affect immunological response | Measuring how specific IBD therapies and doses, during induction or maintenance, interval between vaccination and anti TNF infusion/injection affect the response to the vaccine | 12 months | 
| Immunologic assessments affect response to vaccine | Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine | 12 months | 
| Adverse Events to covid-19 vaccine | Following Adverse reactions to vaccines | 12 months |