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Status unknownNCT04724642Updated Jan 28, 2021

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

An observational study in Allogenic Hematopoietic Cell Transplant, CAR-T Therapy and Primary Immunodeficiency, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
110
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Allogenic Hematopoietic Cell Transplant
  • CAR-T Therapy
  • Primary Immunodeficiency
03

In context

Primary Immunodeficiency Diseases

204 studies on the registry are indexed under Primary Immunodeficiency Diseases; 47 are open to participants now.

This study's planned enrollment of 110 is below the median of 126 across 75 observational studies indexed under Primary Immunodeficiency Diseases.

Browse Primary Immunodeficiency Diseases studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.

Browse Tel-Aviv Sourasky Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Incidence of side effects in patients

    Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination

    Time frame: 10 weeks counting since first vaccination is initiated.

Secondary outcomes

  1. Prevalence of severe adverse reactions

    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

    Time frame: 10 weeks counting since first vaccination is initiated.

07

Study locations

1 of 1 sites recruiting
  • Tel-Aviv Sourasky Medical Center
    Tel Aviv, 6423906, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04724642
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Jan 26, 2021
Start date
Dec 28, 2020
Primary completion
May 28, 2021 (estimated)
Completion
Dec 28, 2021 (estimated)
Last update
Jan 28, 2021

Study contacts

Ron Ram, Prof.
Contact
ronr@tlvmc.gov.il
972-3-6973782 ext. 3782
Ron Ram, Prof
principal investigator · Tel-Aviv Sourasky Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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