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
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