COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency

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Brief Title

COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency

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

Brief Summary

      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.
    

Detailed Description

      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 -

        1. Blood count and lymphocyte subgroup counts before vaccination (up to 48 hours before
           vaccination).

        2. Evaluation of GVHD activity and accompanying toxicity.

        3. Receipt of a letter confirming the vaccination to the HMO.

        4. One-week follow-up after vaccination including blood count, complete chemistry, GVHD
           evaluation, and review of adverse reactions that may be vaccine-related.

        5. Referral for a second dose of the vaccine.

        6. 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 -

        1. 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 -

        2. 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


Primary Outcome

Incidence of side effects in patients

Secondary Outcome

 Prevalence of severe adverse reactions

Condition

Allogenic Hematopoietic Cell Transplant



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

110

Start Date

December 28, 2020

Completion Date

December 28, 2021

Primary Completion Date

May 28, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ron Ram, Prof, 972-3-6973782, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT04724642

Organization ID

1067-20


Responsible Party

Sponsor

Study Sponsor

Tel-Aviv Sourasky Medical Center


Study Sponsor

Ron Ram, Prof, Principal Investigator, Tel-Aviv Sourasky Medical Center


Verification Date

January 2021