Humoral response to SARS-CoV-2 vaccine in multiple sclerosis patients treated with anti-CD20

Abstract

Background: SARS-CoV-2 is a viral infection that causes COVID-19 disease, a pandemic or public health emergency situation we currently live forces the rapid development of a vaccine by compressing developmental stages and optimizing its safety and efficacy data in human use. For its part, Multiple Sclerosis is the most common chronic autoimmune disease of Central Nervous System (CNS). The patients who are receiving immunomodulatory treatment such as anti-CD20 therapy whose response to the vaccine is predicted to be blunted become the epicentre of concern in this protocol. These assumptions are based on previous experience with other vaccines and on the mechanism of action itself. The thin line between spacing out disease control treatment to aid the repopulation of B cells to create a competent immune response against the SARS-CoV-2 vaccine becomes a challenge in the management of such patients. Objective: The aim of this study is to study the dynamics of humoral response against SARS-CoV-2 vaccine in Multiple Sclerosis patients who are receiving anti-CD20 therapy. The long-term goal is to optimize the management of their disease by offering them the possibility to develop immunization against SARS-CoV-2. Methodology: The study will be a prospective cohort conducted in the Santa Caterina’s Hospital using a consecutive method of sampling for a comparison of two cohort groups formed by patients attending to Neuroimmunology and Multiple Sclerosis Unit (cohort 1) and to the International Health Unit (cohort 2). All the participants must fulfil the inclusion criteria and have none of the exclusion ones. Determinations of SARS-CoV-2 antibody in blood pre- and post-vaccine administration will be performed during a follow-up period of 5 months. Once we collected the data a statistical analysis will be performed using Chi-square and Fisher’s Exact test to assessing the relation between dependent and independent variables. A p-value <0.05 will be considered as statistically significant. The association between the dependent and independent variables will be adjusted using co-variables-controlled logistic regression in order to avoid confusion