Abstract
Background: The majority of multiple sclerosis [MS] patients treated with fingolimod fail to develop a protective level of IgG humoral and adaptive cellular immune responses following full BNT162b2 SARS-CoV-2 vaccination.
Objective: To compare the efficacy of the third COVID-19 vaccine dose in vaccine non-responders fingolimod-treated MS patients.
Study design: This is a prospective 3-month, single-center, randomized clinical trial.
Methods: Twenty relapsing MS patients who had been on fingolimod therapy ≥ 12 months and failed to develop humoral IgG immune response to 2-dose Pfizer BNT162b2 COVID-19 vaccination were randomized into two groups: fingolimod-continuation group and fingolimod-discontinuation group. Humoral and memory cellular immune responses were assessed within 1 and 3 months following the third Pfizer BNT162b2 vaccine dose and compared between the groups.
Results: A higher rate of patients in the fingolimod-discontinuation group [n = 8/10] compared to fingolimod-continuation group [n = 2/10] developed positive SARS-COV-2 IgG. Median IgG titer 1 month following the third dose was 202.3 BAU/ml vs. 26.4 BAU/ml, respectively, p = 0.022. The development of IgG humoral response correlated with absolute lymphocyte count. Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose.
Conclusions: Short period of fingolimod treatment discontinuation was associated with the development of humoral protection but not with adaptive cellular immunity.
Keywords: COVID-19; Cellular immunity; Fingolimod; Humoral immunity; IgG antibody; Multiple sclerosis; Third BNT162b2 SARS-CoV-2 vaccine dose.
【저자키워드】 COVID-19, multiple sclerosis, Humoral immunity, IgG antibody, cellular immunity, fingolimod, Third BNT162b2 SARS-CoV-2 vaccine dose., 【초록키워드】 Treatment, IgG, randomized clinical trial, Efficacy, Vaccine, BNT162b2 vaccine, COVID-19 vaccine, immune response, clinical trial, therapy, adaptive, multiple sclerosis, Cellular immune response, SARS-CoV-2 vaccine, memory, BNT162b2, Pfizer, Randomized, lymphocyte, Humoral immunity, T cell, IgG antibody, COVID-19 vaccination, cellular immunity, immune responses, Patient, fingolimod, patients, SARS-CoV-2 vaccination, memory B cell, Protective, Absolute lymphocyte count, dose, humoral, two groups, both groups, single-center, positive, Specific, Multiple, non-responder, Cell, IgG immune response, memory B, adaptive cellular immunity, develop, majority, correlated, groups, in both groups, patients treated, relapsing, were assessed, 【제목키워드】 COVID-19 vaccine, Lymphocyte count, fingolimod, dose, patients treated,