Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04862806

Enrollment

1000

Registered

2021-04-28

Start date

2021-02-01

Completion date

2022-03-31

Last updated

2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, BNT162b2 mRNA Covid-19 Vaccine

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

Interventions

DIAGNOSTIC_TESTCOVID-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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination	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	6 months	To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines

Secondary

Measure	Time frame	Description
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	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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026