In the multivariate analysis including antiCD20 patients, the predictors for a positive humoral response were receiving the mRNA vaccine (OR 8.11 (1.79C36.8), em p /em ?=?0.007) and a lower number of total infusions (OR 0.44 (0.27C0.74) em p /em ?=?0.002. 100% of patients with no DMT ( em n /em ?=?3), 100% with interferon/glatiramer-acetate ( em n /em ?=?11), 100% with teriflunomide/dimethyl-fumarate ( em n /em ?=?16), 100% with natalizumab ( em n /em ?=?10), 100% with alemtuzumab ( em n /em ?=?8), 90% with cladribine ( em n /em ?=?10), and 88% with fingolimod ( em n /em ?=?17), while 43% of patients receiving antiCD20 ( em n /em ?=?99) were positive (38% inactivated vaccine vs. 59% mRNA vaccine, em p /em ?=?0.05). In the multivariate analysis including antiCD20 patients, the predictors for a positive humoral response were receiving the mRNA vaccine (OR 8.11 (1.79C36.8), em p /em ?=?0.007) and a lower number of total infusions (OR 0.44 (0.27C0.74) em p /em ?=?0.002. The most frequent AESAV was local pain (14%), with 4 (2.2%) patients experiencing mild-moderate relapses within 8 weeks of first vaccination compared to 11 relapses (6.2%) within the 8 weeks before vaccination (Chi-squared 3.41, em p /em ?=?0.06). Discussion A higher humoral response rate was observed using the mRNA compared to the inactivated vaccine, while patients using antiCD20 had a significantly lower response rate, and patients using antiCD20 and fingolimod had lower antibody titres. In this CTEP MS patient cohort, inactivated and mRNA vaccines against SARS-CoV-2 appear to be safe, with no increase in relapse rate. This information may help guidelines including booster shots and types of vaccines in selected populations. strong class=”kwd-title” Keywords: Multiple sclerosis, Vaccine, COVID-19, SARS-CoV-2, Humoral CTEP response, inactivated virus, mRNA 1.?Introduction Vaccination strategies against SARS-CoV-2 have been implemented worldwide, with different approaches considering available scientific information and local governmental policies. The most common mechanisms of action include inactivated vaccines (e.g. Sinopharm, Sinovac) in which the target antigen is against the whole virus, producing mostly a humoral immune response CTEP (anti-Spike-IgG and anti-Nucleocapsid-IgG), non-replicating viral vector vaccines (e.g. Oxford/Astrazeneca, CanSino, Johnson & Johnson/Janssen), against the Spike-protein CTEP with both humoral and cellular immune response, and the novel mRNA vaccines (e.g. Pfizer-BioNTech, Moderna), also against the Spike-protein producing a humoral and cellular immune response (Sharma?et?al., 2020). Recommendations from Multiple Sclerosis (MS) expert groups were published and distributed, and to date, safety and effectiveness outcomes in MS patients receiving different disease-modifying therapies (DMT) and different types of vaccines are being published (Achiron?et?al., 2021a, b, Allen-Philbey?et?al., 2021; Kelly?et?al., 2021; Tallantyre?et?al., 2021 Ali?et?al., 2021 Oct 1), with limited data especially for inactivated vaccines (Ali?Sarahian et?al., 2021), and prospective multicentric databases are essential for guiding future recommendations. We aimed to assess the safety and humoral response rates of anti-SARS-CoV-2 vaccines in patients with MS, with an emphasis on patients receiving inactivated virus and mRNA vaccines. 2.?Methods Multicentric, prospective, observational study including consecutive MS patients (McDonald 2017 criteria) 18 years old, receiving regular clinical care at 4 tertiary MS centres (Hospital Clnico UC, Hospital Dr. Stero del Ro, Clnica Alemana de Santiago, and Clnica Dvila) in Santiago, Chile, who had Rabbit Polyclonal to PKR1 completed vaccination schedules against SARS-CoV-2 between February and September 2021. The type CTEP of vaccine inoculated (inactivated virus (Sinovac-Coronavac), mRNA (Pfizer-BioNtech), adenoviral vector (CanSino, Johnson&Johnson-Jannsen, Oxford-AstraZeneca) was determined according to the availability at each vaccination centre. This is part of an ongoing observational study including follow-up for at least 1 year of the first dose of anti-SARS-CoV-2 vaccination. Clinical data, MS variables, and the history of COVID-19 before vaccination and DMT use during inoculation was recorded. Humoral immune response was determined at least 4 weeks after the second dose of either vaccine, by assessing antibodies (IgG and IgM) against spike 1 (S1) and nucleocapsid (N) proteins (ECLIA Cobas, Roche). A categorical result (positive/negative) using the manufacturer cut-off parameters (positive 0.80?U/mL for anti-S1 and a ratio 1 for anti-N) as well as total antibody levels were recorded. Although this study used a non-probability sampling based on the convenience of consecutive patients, a low source of bias is expected because of the demographic and clinical characteristics of the.
