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Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

NCT04862806 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2021-09-17

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Ziv Medical Center

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Ben-Gurion University of the Negev

    collaborator OTHER

  • Galilee Medical Center

    collaborator UNKNOWN

  • Kaplan Medical Center

    collaborator OTHER

  • Meir Medical Center

    collaborator OTHER

  • Soroka University Medical Center

    collaborator OTHER

  • Rambam Health Care Campus

    collaborator OTHER

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Rabin Medical Center

    collaborator OTHER

  • Sourasky Medical Center

    collaborator UNKNOWN

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-09-30
Completion
2022-03-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862806 on ClinicalTrials.gov