Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

Bnai Zion Medical Center1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,000

Conditions

Chronic Lymphocytic Leukemia

Interventions

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

Hematology Division, Chaim Sheba Medical Center

Tel Aviv, Israel

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination

Data from ClinicalTrials.gov

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