Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination.

Abstract

Patients with chronic lymphocytic leukemia (CLL) have an impaired antibody response to coronavirus disease 2019 (COVID-19) vaccination. Here, we evaluated the antibody response to a third BNT162b2 mRNA vaccine in patients with CLL/small lymphocytic lymphoma (SLL) who failed to achieve a humoral response after standard 2-dose vaccination regimen. Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies were measured 3 weeks after administration of the third dose. In 172 patients with CLL, the antibody response rate was 23.8%. Response rate among actively treated patients (12.0%; n = 12/100) was lower compared with treatment-naïve patients (40.0%; n = 16/40; OR = 4.9, 95% CI 1.9-12.9; P < .001) and patients off-therapy (40.6%; n = 13/32; OR = 5.0, 95% CI 1.8-14.1; P < .001), (P < .001). In patients actively treated with Bruton's tyrosine kinase (BTK) inhibitors or venetoclax ± anti-CD20 antibody, response rates were extremely low (15.3%, n = 9/59, and 7.7%, n = 3/39, respectively). Only 1 of the 28 patients (3.6%) treated with anti-CD20 antibodies <12 months prior to vaccination responded. In a multivariate analysis, the independent variables that were associated with response included lack of active therapy (OR = 5.6, 95% CI 2.3-13.8; P < .001) and serum immunoglobulin A levels ≥80 mg/dL (OR = 5.8, 95% CI 2.1-15.9; P < .001). In patients with CLL/SLL who failed to achieve a humoral response after standard 2-dose BNT162b2 mRNA vaccination regimen, close to a quarter responded to the third dose of vaccine. The antibody response rates were lower during active treatment and in patients with a recent exposure (<12 months prior to vaccination) to anti-CD20 therapy. This trial was registered at www.clinicaltrials.gov as #NCT04862806.

• Authors: Yair Herishanu, Galia Rahav, Shai Levi, Andrei Braester, Gilad Itchaki, Osnat Bairey, Najib Dally, Lev Shvidel, Tomer Ziv-Baran, Aaron Polliack, Tamar Tadmor, Ohad Benjamini, Israeli CLL Study Group
• Journal: Blood (Blood) Vol. 139 Issue 5 Pg. 678-685 (02 03 2022) ISSN: 1528-0020 [Electronic] United States
• PMID: 34861036 (Publication Type: Clinical Trial, Journal Article)
• Copyright: © 2022 by The American Society of Hematology.

Chemical References

• Antibodies, Viral
• BNT162 Vaccine

Topics

• Aged
• Antibodies, Viral (blood, immunology)
• Antibody Formation
• BNT162 Vaccine (administration & dosage, therapeutic use)
• COVID-19 (blood, immunology, prevention & control)
• Female
• Humans
• Immunity, Humoral
• Leukemia, Lymphocytic, Chronic, B-Cell (blood, complications, immunology)
• Male
• Middle Aged
• SARS-CoV-2 (immunology)
• Vaccine Efficacy