ABSTRACT
Introduction: The vaccination against SARS-CoV-2 is the main strategy to contain the pandemic and minimize hospitalizations principally in people with chronic diseases such multiple sclerosis (MS). Disease-modifyng therapies (DMTs) may impact on vaccine responses in MS people. Objective and Aims: To evaluate humoral and T-cell response after SARS-CoV-2 mRNA vaccine in MS people treated with different DMTs. Method(s): 130 MS patients treated with different DMTs were recruited, blood samples for detection of SARS-CoV-2 antibodies were collected at T0, before the first dose of vaccine, at T1, before the second dose, and T2 one month after. In a subgroup of 51 patients and 20 controls, samples were collected at T0 and T2 to test T-cell immune response to Spike antigen of SARS-CoV-2 by ELISPOT-IFNgamma. Result(s): All 130 patients had negative SARS-CoV-2 antibodies before vaccination, 66% showed IgG response to the first dose of vaccine (mean [SD],757[852] AU/mL), and 88,5% after the second dose (7259,06[7251]).The IgG response rate to vaccine was 100% (20/20) in healthy controls and MS patients treated with teriflunomide (5/5), dimethyl-fumarate (5/5) and natalizumab (9/9), while it was significantly lower in patients treated with fingolimod (76.2%, 16/21) and ocrelizumab (36.4%, 4/11). The IgG levels in fingolimod (552.3 [957.9]) and ocrelizumab (159.1 [301.2]) were also significantly lower than healthy controls (P<0.0001). We detected positive Spike-specific T-cell responses in 100% of vaccinated healthy controls and patients treated with teriflunomide, dimethyl-fumarate and natalizumab, in 90.5% (19/21) of patients treated with fingolimod, and 63.8% (7/11) of patients treated with ocrelizumab. Conclusion(s): The study confirm that the mRNA vaccine induce humoral specific responses in the majority of DMT-treated SM patients. It is noticeable the development of a T- cell-specific response to SARS-CoV-2 in patients treated with fingolimod and ocrelizumab, even with lower rates of humoral response. These findings encourage SARS-CoV-2 vaccination in all MS patients treated with DMTs.
ABSTRACT
SARS-CoV-2 is a betacoronavirus, which induced a severe pandemic infectious disease around the world. Even if several drugs have been suggested for its treatment, to date, the only strategy to reduce the severity of disease is represented by the use of vaccine. However, the lack of pre-marketing evidence in frail patients suggests the necessity of the real-world study of a vaccine benefit-risk profile. In this study, we evaluated the efficacy and the safety of SARS-CoV-2 vaccination in a cohort of 33 patients treated with an immunosuppressant after solid organ transplant. Both CLIA and LS/MS analysis were used to evaluate the levels of immunoglobulin (Ig)G anti SARS-CoV-2 and the therapeutic drug monitoring of immunosuppressant drugs. We documented that SARS-CoV-2 vaccination induced a dose- and gender-related serological response. In particular, in 63.6% of the enrolled patients, we documented a significant serological response at T2, and after a time related decrease, the booster dose induced a serological response in 72.7% of enrolled patients. In conclusion, the vaccine anti SARS-CoV-2 is immunogenic in patients under immunosuppression, and is not related to the development of ADRs. We also suggest that the booster dose could be used to increase the efficacy of the vaccination, particularly in women.