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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724642
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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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.


Condition or disease
Allogenic Hematopoietic Cell Transplant CAR-T Therapy Primary Immunodeficiency

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 Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prevalence of severe adverse reactions [ Time Frame: 10 weeks counting since first vaccination is initiated. ]
    1. Prevalence of severe adverse reactions (grade 3-4) in patients post allogeneic bone marrow transplantation after vaccination with COVID-19
    2. Percentage of patients with SEROCONVERSION to COVID-19 (IgG Anti S)

    3. 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.

    4. Infection with COVID19, according to a PCR test from a nasopharyngeal sample


Biospecimen Retention:   Samples Without DNA
Blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
70 patients after allogeneic bone marrow transplant or after CART therapy and 40 patients with a primary immunodeficiency.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ron Ram, Prof. 972-3-6973782 ext 3782 ronr@tlvmc.gov.il

Locations
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Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 6423906
Contact: Ron Ram, Prof.    972-3-6973782 ext 3782    ronr@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ron Ram, Prof Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04724642    
Other Study ID Numbers: 1067-20
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn