COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency
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|ClinicalTrials.gov Identifier: NCT04724642|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 28, 2021
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.
|Condition or disease|
|Allogenic Hematopoietic Cell Transplant CAR-T Therapy Primary Immunodeficiency|
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 -
- Blood count and lymphocyte subgroup counts before vaccination (up to 48 hours before vaccination).
- Evaluation of GVHD activity and accompanying toxicity.
- Receipt of a letter confirming the vaccination to the HMO.
- One-week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, and review of adverse reactions that may be vaccine-related.
- Referral for a second dose of the vaccine.
- One week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, review of side effects that may be vaccine related.
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
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|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|
|Actual Study Start Date :||December 28, 2020|
|Estimated Primary Completion Date :||May 28, 2021|
|Estimated Study Completion Date :||December 28, 2021|
- Incidence of side effects in patients [ Time Frame: 10 weeks counting since first vaccination is initiated. ]Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination
- Prevalence of severe adverse reactions [ Time Frame: 10 weeks counting since first vaccination is initiated. ]
- 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724642
|Contact: Ron Ram, Prof.||972-3-6973782 ext firstname.lastname@example.org|
|Tel-Aviv Sourasky Medical Center||Recruiting|
|Tel-Aviv, Israel, 6423906|
|Contact: Ron Ram, Prof. 972-3-6973782 ext 3782 email@example.com|
|Principal Investigator:||Ron Ram, Prof||Tel-Aviv Sourasky Medical Center|