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The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19).
The purpose of the study is to confirm the accepted hypothesis from the recommendations of The European Society for Blood and Marrow Transplantation, that the vaccine for COVID-19 is safe and has good efficacy in immunocompromised patients after a bone marrow transplant from a donor / cellular therapy.
The study population will be allogeneic bone marrow transplant patients and those who have received CART therapy - immunocompromised patients who are vaccinated with COVID-19 in a commercial preparation, regardless of the study.
The following procedures are routinely performed before receiving the vaccine in the bone marrow transplant unit -
The following procedures are performed only as part of the study -
Serology test (IgG AntiS) two weeks after the second dose of the vaccine to test the effectiveness of the vaccine.
Cell separation two weeks after the second vaccination and execution -
ELISpot test to test for the release of interferon gamma in response to the stimulation of cells separated with the SARS-COV-2 virus peptides (stimulation with S peptides to evaluate vaccine response, and stimulation with M peptides as a control).
All data collected in the study will be typed into Excel and analyzed using SPSS version 25.0. Continuous data will be described using averages and standard deviations, and categorical data will be described using prevalence and percentages.
The distribution of the continuous variables will be presented using an outline graph and will be examined using the Kolmogorov Smirnov test.
An attempt will be made to perform subgroup analysis (depending on the frequency of the groups in the sample) for the patient group:
Patients after bone marrow transplantation with acute GVHD Patients after bone marrow transplantation with chronic GVHD Patients after bone marrow transplantation without immunosuppressive therapy Patients after Cell Therapy (CART) Patients lack primary immunization
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of side effects in patients | Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination | 10 weeks counting since first vaccination is initiated. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of severe adverse reactions |
|
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Inclusion Criteria:
Exclusion Criteria:
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70 patients after allogeneic bone marrow transplant or after CART therapy and 40 patients with a primary immunodeficiency.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ron Ram, Prof. | Contact | 972-3-6973782 | 3782 | ronr@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ron Ram, Prof | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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Blood sample
| 10 weeks counting since first vaccination is initiated. |