Primary Immunodeficiency Clinical Trial
Official title:
Efficacy and Safety of COVID-19 Vaccine in Patients After Allogeneic Hamatopoietic Cell Transplantation, CAR-T Therapy and With Primary Immune Deficiency - a Post Marketing Prospective Cohort Study
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 28, 2021 |
Est. primary completion date | May 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged 18 and over - Patient sex - male and female - Bone marrow transplant from a donor (sibling or unrelated) or after cell therapy (CART) at least 3 months before vaccination. - Patients with primary immunodeficiency syndrome. - Patients who are able to sign an informed consent form Exclusion Criteria: - Patients under 18 years of age - Patients who are unable to give informed consent - Patients with acute GVHD who require steroid therapy above 0.5 mg / kg or who have been diagnosed in the last month. - Patients with chronic GVHD who require steroid therapy above 0.5 mg / kg - Patients treated with rituximab / immunoglobulins / mesenchymal cells during the last month. - Patients whose disease is not completely cured and receive dedicated treatment for the disease. - Patients receiving maintenance treatment for the underlying disease (excluding TKIs such as sorfenib, midostaurin, guiltritinib or cranolinib). - Patients who have previously had COVID19. - Patients with severe allergy to one of the vaccine components. |
Country | Name | City | State |
---|---|---|---|
Israel | Tel-Aviv Sourasky Medical Center | Tel-Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | Prevalence of severe adverse reactions | Prevalence of severe adverse reactions (grade 3-4) in patients post allogeneic bone marrow transplantation after vaccination with COVID-19
Percentage of patients with SEROCONVERSION to COVID-19 (IgG Anti S) Exacerbation rates in GVHD - Acute GVHD - Exacerbation of GVHD in at least one organ by at least one grade without continued improvement of GVHD in the other affected organs. Chronic GVHD - Exacerbation of GVHD in each of the organs involved. Infection with COVID19, according to a PCR test from a nasopharyngeal sample |
10 weeks counting since first vaccination is initiated. |
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