Allogenic Hematopoietic Cell TransplantNCT04724642
COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency
An observational study of Allogenic Hematopoietic Cell Transplant and CAR-T Therapy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Hematopoietic Cell Transplant, CAR-T Therapy, Primary Immunodeficiency
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Dec 2020to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients after allogeneic bone marrow transplant or after CART therapy and 40 patients with a primary immunodeficiency.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Ron Ram, Prof., 972-3-6973782 ext. 3782, ronr@tlvmc.gov.il
About this study
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.
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 -
- 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
- Medical subject headings
- Primary Immunodeficiency Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of side effects in patients
Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination
Measured: 10 weeks counting since first vaccination is initiated.
Secondary outcomes (1)
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
Measured: 10 weeks counting since first vaccination is initiated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start28 Dec 2020
- Primary completion28 May 2021 (estimated)
- Study completion28 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ron Ram, Prof, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724642
- Sponsor's protocol ID
- 1067-20
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04724642
- Acronym / sponsor ID
- 1067-20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 28 May 2021 (estimated)
- Study completion
- 28 Dec 2021 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 -
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients after allogeneic bone marrow transplant or after CART therapy and 40 patients with a primary immunodeficiency.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Prevalence of severe adverse reactions
Time frame: 10 weeks counting since first vaccination is initiated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Ram, Prof principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogenic Hematopoietic Cell Transplant and CAR-T Therapy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Ram, Prof. (972-3-6973782 ext. 3782, ronr@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of side effects in patients (time frame: 10 weeks counting since first vaccination is initiated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.