Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

Bnai Zion Medical Center

Status: Unknown

Conditions: Chronic Lymphocytic Leukemia

Treatments: Diagnostic Test: COVID-19 serology

Study type: Interventional

Funder types: Other

Identifiers

NCT04862806

0214-20-BNZ

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Israel CLL study group

Experimental group

Description:

BNT162b2 mRNA vaccine

Treatment:

Diagnostic Test: COVID-19 serology