NCT04862806

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 17, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

March 21, 2021

Last Update Submit

September 11, 2021

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLBNT162b2 mRNA Covid-19 Vaccine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.

    2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination

Study Arms (1)

Israel CLL study group

EXPERIMENTAL

BNT162b2 mRNA vaccine

Diagnostic Test: COVID-19 serology

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).

Israel CLL study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CLL was according to the IWCLL criteria
  • All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).

You may not qualify if:

  • previous covid19 virus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Hematology Division, Chaim Sheba Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

  • Herishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085.

    PMID: 34861036DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSerologic TestsImmunologic TestsInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HEAD OF HEMATOLOGY

Study Record Dates

First Submitted

March 21, 2021

First Posted

April 28, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

September 17, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)