Abstract
Background: The assessment of the safety and the humoral response to a third booster dose of the BNT162b2 mRNA COVID-19 vaccine is relevant in patients with Multiple Sclerosis (pwMS) treated with Ocrelizumab (OCR) or Fingolimod (FNG).
Methods: Serum samples were collected from Healthy controls (HCs) and pwMS treated with OCR or FNG at the following time-points: before the first of two vaccine doses (T0); 8 (T1), 16 (T2), 24 (T3) weeks after the first dose; within 8 weeks before (T0b) and after (T1b) the booster dose. IgG antibodies to SARS-CoV-2 trimeric spike protein (Anti-TSP IgG) were quantified and expressed as binding antibody units (BAU)/mL.
Results: 40 HCs, 28 pwMS on OCR and 19 on FNG were included. At T0b 12 (42.9%) pwMS on OCR and 6 (31.6%) on FNG were still positive while, at T1b 16 (57.14%) pwMS on OCR and 16 (84.2%) on FNG, passed the threshold of positivity. The increase of Anti-TSP IgG levels at T1b was higher for: (i) HCs with respect to OCR (p < 0.001) and FNG (p = 0.032) groups; (ii) pwMS on FNG compared with pwMS on OCR (p < 0.001). No socio-demographic, clinical or laboratory variables were able to predict the anti-TSP IgG increase between T0b and T1b. Neither clinical relapses nor severe adverse events were reported in pwMS after each dose of vaccine.
Conclusions: The third booster dose of BNT162b2 mRNA vaccine to OCR- and FNG-treated pwMS revives the humoral response, independently of any clinical variable, and manifests a good safety and tolerability profile.
Keywords: BNT162b2 mRNA vaccine; Booster dose; COVID-19; Fingolimod; Ocrelizumab.
【저자키워드】 COVID-19, fingolimod, booster dose, BNT162b2 mRNA vaccine, Ocrelizumab., 【초록키워드】 SARS-CoV-2, IgG, Vaccine, COVID-19 vaccine, mRNA vaccine, Laboratory, vaccine dose, IgG antibody, Patient, Control, Trimeric spike protein, threshold, predict, BNT162b2 mRNA, Ocrelizumab, dose, humoral, Tolerability, positive, Multiple, sclerosis, serum sample, variable, socio-demographic, collected, reported, treated, expressed, quantified, binding antibody unit, HCs, IgG level, of BNT162b2, severe adverse event, 【제목키워드】 COVID-19 vaccine, multiple sclerosis, Humoral response, mRNA, Patient, treated, of BNT162b2,