Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

NCT ID: NCT04862806

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Israel CLL study group

BNT162b2 mRNA vaccine

Group Type EXPERIMENTAL

COVID-19 serology

Intervention Type DIAGNOSTIC_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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ziv Medical Center

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Galilee Medical Center

UNKNOWN

Sponsor Role collaborator

Kaplan Medical Center

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role collaborator

Sourasky Medical Center

UNKNOWN

Sponsor Role collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

tamar.tadmor

HEAD OF HEMATOLOGY

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Hematology Division, Chaim Sheba Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tamar Tadmor, MD

Role: primary

+97248359 ext. 407

Ohad Benjamini

Role: primary

00972526669155

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34861036 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0214-20-BNZ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mosunetuzumab for CLL MRD Clearance
NCT07052695 RECRUITING PHASE1/PHASE2