Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

Study Overview
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Brief Summary
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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

Official Title
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Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Diagnostic Test: COVID-19 serology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Israel CLL study group<br>BNT162b2 mRNA vaccine | Diagnostic Test: COVID-19 serology<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, BNT162b2 mRNA Covid-19 Vaccine