Chronic Lymphocytic LeukemiaNCT04862806
Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL
A study testing COVID-19 serology in people with Chronic Lymphocytic Leukemia, run by Bnai Zion Medical Center at 2 sites in Israel.
Trial summary
On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- COVID-19 serology
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Feb 2021to Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of CLL was according to the IWCLL criteria
- All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).
Who cannot join
- previous covid19 virus infection
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
Tamar Tadmor, MD, +97248359 ext. 407, tamar.tadmor@b-zion.org.il
- Recruiting
Hematology Division, Chaim Sheba Medical Center
Tel Aviv
Ohad Benjamini, 00972526669155, ohadb.mail@gmail.com
About this study
Official title: Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- COVID-19 serology
- Keywords
- CLL, BNT162b2 mRNA Covid-19 Vaccine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 serologyDiagnostic test
Immune response to BNT162b2 mRNA vaccine is assessed on the basis of anti covid19 IgG levels. A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value > 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value >15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value >1.1; range 1.1-10).
| Study group | Role | What they receive |
|---|---|---|
| Israel CLL study group | Experimental | BNT162b2 mRNA vaccine Receives: Diagnostic Test: COVID-19 serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
Answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire on the same clinic visit when blood is drawn for serologic tests.
Measured: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines
Measured: 6 months
Secondary outcomes (1)
Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.
A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value > 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value >15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value >1.1; range 1.1-10).
Measured: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Feb 2021
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled CLL patients have received 2 shots of BNT162b2 mRNA vaccine, and the investigators will check the efficacy and safety of this vaccine in the enrolled population- the intervention is the diagnostic test of COVID-19 serology
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Ziv Medical Center, Hadassah Medical Organization, Ben-Gurion University of the Negev, Galilee Medical Center, Kaplan Medical Center, Meir Medical Center, Soroka University Medical Center, Rambam Health Care Campus, Sheba Medical Center, Rabin Medical Center, Sourasky Medical Center
- Responsible party
- Principal investigator, tamar.tadmor, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862806
- Sponsor's protocol ID
- 0214-20-BNZ
- Status last verified
- Apr 2021
- First submitted
- 21 Mar 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085.
PubMed 34861036
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
- ClinicalTrials.gov ID
- NCT04862806
- Acronym / sponsor ID
- 0214-20-BNZ
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, BNT162b2 mRNA Covid-19 Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Ziv Medical Center, Hadassah Medical Organization, Ben-Gurion University of the Negev, Galilee Medical Center, Kaplan Medical Center, Meir Medical Center, Soroka University Medical Center, Rambam Health Care Campus, Sheba Medical Center, Rabin Medical Center, Sourasky Medical Center
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Apr 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.
On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled CLL patients have received 2 shots of BNT162b2 mRNA vaccine, and the investigators will check the efficacy and safety of this vaccine in the enrolled population- the intervention is the diagnostic test of COVID-19 serology
| Arm | Type | Receives |
|---|---|---|
| Israel CLL study group | Experimental | Diagnostic Test: COVID-19 serologyBNT162b2 mRNA vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CLL was according to the IWCLL criteria
- All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).
Key exclusion criteria (1 listed)
- previous covid19 virus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 serologyImmune response to BNT162b2 mRNA vaccine is assessed on the basis of anti covid19 IgG levels. A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value > 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value >15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value >1.1; range 1.1-10). | Diagnostic test | Israel CLL study group |
Primary outcome
Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
Time frame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire on the same clinic visit when blood is drawn for serologic tests.
Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
Time frame: 6 months
To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines
1 secondary outcome
Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.
Time frame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 34861036Herishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 serology in people with Chronic Lymphocytic Leukemia, run by Bnai Zion Medical Center at 2 sites 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 2 inclusion and 1 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators. (time frame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862806, which also lists 1 linked publication.
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 17 Sep 2021.