Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia

Abstract

Patients with chronic lymphocytic leukemia (CLL) have an increased risk for severe COVID-19 disease and mortality. The goal of this study (NCT04746092) was to determine the efficacy of COVID-19 vaccine in patients with CLL. We evaluated humoral immune responses to BNT162b2 mRNA COVID-19 vaccine in patients with CLL and compared responses with those obtained in age-matched healthy controls. Patients received two vaccine doses, 21 days apart, and antibody titers were measured using Elecsys® Anti-SARS-CoV-2S assay after administration of the second dose. In a total of 167 patients with CLL the antibody response rate was 39.5%. A comparison between 52 patients with CLL and 52 sex- and aged-matched healthy controls, revealed a significantly reduced response rate among patients (52% vs 100%, respectively; adjusted odds ratio=0.010, 95% CI 0.001-0.162; p<0.001). Response rate was highest in patients who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naïve and 16% only in patients under treatment at the time of vaccination. In patients treated with either BTK inhibitors or venetoclax ± anti-CD20 antibody, response rates were considerably low (16.0% and 13.6%, respectively). None of the patients exposed to anti-CD20 antibodies <12 months prior to vaccination responded. In a multivariate analysis, the independent predictors of response were younger age, females, lack of currently active treatment, IgG levels ≥550 mg/dL and IgM levels ≥40mg/dL. In conclusion, antibody-mediated response to BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment.

Fifth-week immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in patients with multiple myeloma and myeloproliferative malignancies on active treatment: preliminary data from a single institution

“…It is highly desirable that vaccines against SARS-CoV-2, hopefully including its variants, could work also in hematological malignancy patients. Such patients were not enrolled in the registration trials, and, so far, no data on COVID-19 vaccines for this vulnerable population have been published, except for chronic lymphocytic leukemia [ 1 ]. Therefore, recommendations and expectations in clinical practice are based on evidences coming from the immune response to COVID-19 infection and non-COVID-19 vaccines [ 2 ].…”

Antibody responses after SARS-CoV-2 vaccination in patients with lymphoma

“…Data on vaccine responses in chronic lymphocytic leukaemia have shown antibody responses in 52–75% of individuals after the second dose. 1 , 2 Vaccine responses after two doses in people with other lymphoid malignancies remain undefined.…”

Current perspectives for SARS-CoV-2 vaccination efficacy improvement in patients with active treatment against cancer

“…[ 23 ] Seroconversion if neutralising anti-S Ab inhibition titres ≥ 30% (ELISA, cPassTM SARS-CoV-2 NAbs Detection Kit; GenScript, Piscataway, NJ, USA) HV Elderly MM pts 57 (54.8%) 12 (25.0%) Herishanu et al. [ 24 ] Seroconversion if total IgG, IgA, IgM against anti-S ≥ 0.8 IU/mL (Elecsys ® anti-SARS-CoV-2 immunoassay [Roche Diagnostics, France]) CLL (total population) pts CLL treatment-nai¨ve pts CLL actively treated pts CLL pts treated with anti-CD20 Ab (n = 22) within the last 12 months CLL pts exposed to anti-CD20 Ab ≥12 months before vaccination 66 (39.5%) 23 (55.2%) 12 (16%) 0 (0%) 25 (45.5%) Ab: antibodies; Anti-S: anti-spike antibodies; pts: patients; w: week; HV: healthy volunteer; CT: chemotherapy; TT: targeted therapy; MM: multiple myeloma; CLL: chronic lymphocytic leukaemia SC: solid cancer;. …”

“…In elderly patients with multiple myeloma, after the first dose of the BNT162b2 vaccine, a low neutralising antibody response against SARS-CoV-2 was reported [ 23 ]. In 167 patients with chronic lymphocytic leukaemia (CLL), the seroconversion rate was 39.5% after two doses [ 24 ]. A comparison between 52 patients with CLL and 52 sex- and age-matched healthy controls revealed a significantly reduced response rate among patients (52% vs 100%, p < 0.001).…”