Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862806
• Other study ID #: 0214-20-BNZ
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell

Intervention

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).

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa
Israel	Hematology Division, Chaim Sheba Medical Center	Tel Aviv

Sponsors (12)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Ben-Gurion University of the Negev, Galilee Medical Center, Hadassah Medical Center, Kaplan Medical Center, Meir Medical Center, Rabin Medical Center, Rambam Health Care Campus, Sheba Medical Center, Soroka University Medical Center, Sourasky Medical Center, Ziv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination