Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2021-02-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Israel CLL study group
BNT162b2 mRNA vaccine
COVID-19 serology
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).
Interventions
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COVID-19 serology
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).
Eligibility Criteria
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Inclusion Criteria
* All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ziv Medical Center
OTHER
Hadassah Medical Organization
OTHER
Ben-Gurion University of the Negev
OTHER
Galilee Medical Center
UNKNOWN
Kaplan Medical Center
OTHER
Meir Medical Center
OTHER
Soroka University Medical Center
OTHER
Rambam Health Care Campus
OTHER
Sheba Medical Center
OTHER_GOV
Rabin Medical Center
OTHER
Sourasky Medical Center
UNKNOWN
Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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tamar.tadmor
HEAD OF HEMATOLOGY
Locations
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Bnai Zion Medical Center
Haifa, , Israel
Hematology Division, Chaim Sheba Medical Center
Tel Aviv, , Israel
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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0214-20-BNZ
Identifier Type: -
Identifier Source: org_study_id
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