NCT04862806

Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-09-01
• Completion: 2022-03-01
• First posted: 2021-04-28
• Last updated: 2021-09-17

Locations

2 sites across 1 country: Israel