Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

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

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

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

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).

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.

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

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).

2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination

Inclusion Criteria: Diagnosis of CLL was according to the IWCLL criteria All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer). Exclusion Criteria: previous covid19 virus infection

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.