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Serological SARS-CoV-2 antibody response, potential predictive markers and safety of BNT162b2 mRNA COVID-19 vaccine in haematological and oncological patients #MMPMID34346068
Benda M; Mutschlechner B; Ulmer H; Grabher C; Severgnini L; Volgger A; Reimann P; Lang T; Atzl M; Huynh M; Gasser K; Petrausch U; Fraunberger P; Hartmann B; Winder T
Br J Haematol 2021[Nov]; 195 (4): 523-531 PMID34346068show ga
Haemato-oncological patients are at risk in case of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Currently, vaccination is the best-evaluated preventive strategy. In the present study, we aimed to assess serological response, predictive markers, and safety of BNT162b2 in haemato-oncological patients. A total of 259 haemato-oncological patients were vaccinated with two 30 microg doses of BNT162b2 administered 21 days apart. Serological response was assessed by ELECSYS((R)) Anti-SARS-CoV-2-S immunoassay before vaccination, and at 3 and 7 weeks after the first dose (T1, T2). Safety assessment was performed. At T2 spike protein receptor binding domain (S/RBD) antibodies were detected in 71.4% of haematological and in 94.5% of oncological patients (P < 0.001). Haematological patients receiving systemic treatment had a 14.2-fold increased risk of non-responding (95% confidence interval 3.2-63.3, P = 0.001). Subgroups of patients with lymphoma or chronic lymphocytic leukaemia were at highest risk of serological non-response. Low immunoglobulin G (IgG) level, lymphocyte- and natural killer (NK)-cell counts were significantly associated with poor serological response (P < 0.05). Vaccination was well tolerated with only 2.7% of patients reporting severe side-effects. Patients with side-effects developed a higher S/RBD-antibody titre compared to patients without side-effects (P = 0.038). Haematological patients under treatment were at highest risk of serological non-response. Low lymphocytes, NK cells and IgG levels were found to be associated with serological non-response. Serological response in oncological patients was encouraging. The use of BNT162b2 is safe in haemato-oncological patients.
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Br+J+Haematol 2021 ; 195 (4): 523-531
