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Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
COVID-19 serology
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Lymphocytic Leukemia focused on measuring CLL, BNT162b2 mRNA Covid-19 Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bnai Zion Medical CenterRecruiting
  • Hematology Division, Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Israel CLL study group

Arm Description

BNT162b2 mRNA vaccine

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2021
Last Updated
September 11, 2021
Sponsor
Bnai Zion Medical Center
Collaborators
Ziv Medical Center, Hadassah Medical Organization, Ben-Gurion University of the Negev, Galilee Medical Center, Kaplan Medical Center, Meir Medical Center, Soroka University Medical Center, Rambam Health Care Campus, Sheba Medical Center, Rabin Medical Center, Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04862806
Brief Title
Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL
Official Title
Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center
Collaborators
Ziv Medical Center, Hadassah Medical Organization, Ben-Gurion University of the Negev, Galilee Medical Center, Kaplan Medical Center, Meir Medical Center, Soroka University Medical Center, Rambam Health Care Campus, Sheba Medical Center, Rabin Medical Center, Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
CLL, BNT162b2 mRNA Covid-19 Vaccine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Israel CLL study group
Arm Type
Experimental
Arm Description
BNT162b2 mRNA vaccine
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID-19 serology
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Title
Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
Description
To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.
Description
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).
Time Frame
2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Tadmor, MD
Phone
+97248359
Ext
407
Email
tamar.tadmor@b-zion.org.il
Facility Name
Hematology Division, Chaim Sheba Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ohad Benjamini
Phone
00972526669155
Email
ohadb.mail@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34861036
Citation
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.
Results Reference
derived

Learn more about this trial

Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

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