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| Name | Class |
|---|---|
| Shaare Zedek Medical Center | OTHER |
| Soroka University Medical Center | OTHER |
| Emek Medical Center | OTHER |
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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.
Overall Aims:
Specifically:
To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | 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 |
| |
| Controls | healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 vaccine | Biological | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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IBD patients and healthy volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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complete blood count, CRP, Anti-TNF level and trough from relevant patients, COVID-19 serology including neutralizing antibodies, cytokine levels, lymphocyte subpopulation [CD4 CD8 B CD20/19, NKT], T cell proliferation, immunoglobulin levels.
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |