Immunisation Status and Safety of Vaccines in Italian MS Patients

Summary

Multiple sclerosis (MS) patients are more susceptible to infections than the general population in relation to some specific therapies or increasing disability. Clearly, the use of immuno-suppressant/modulatory drugs requires particular attention to the occurrence of infectious events. In this perspective, among still unmet clinical needs in MS patients is a comprehensive picture on the immunisation status against infectious diseases, especially those preventable with vaccines. Despite of the relevance of vaccinations, there are still some concerns about their utilization in MS patients. In literature, results about their safety are conflicting or incomplete and it is yet unclear if some vaccines may trigger MS relapses.

GOALS: 1) to assess immunisation status, due to past exposure to natural infectious diseases or vaccines, against major infectious agents preventable by available vaccines; 2) to assess the safety of most utilized vaccines in the clinical practice by recording relapses as adverse event in the considered risk period after vaccination.

The 3-year project is conceived as a multicenter, observational, both retro- and prospective study. A cohort of about 3,000 MS subjects will be enrolled among databases of 25 clinical Centers in Italy. All patients diagnosed with relapsing remitting (RR) MS according to the 2010 Polman's criteria from 01/2011 to 12/2020 will be enrolled. Available data on natural immunisation will be collected from the historical clinical records of Centers, taking into account the presence of specific serum antibodies, whereas available data on vaccinations will be collected from vaccination records.

To study the impact of vaccines on the risk of relapse, data about patients receiving a vaccination during the disease will be analysed. The study follow-up period will be between 2 and up to 6 months following vaccination: the 2-month period is considered as the maximum clinical risk, whereas 6 months as the maximal extension of risk in time. In addition, in the case of a clinical relapse, the variation of disability will be evaluated with EDSS scale confirmed at 6 months. These data might shed light on the relationship between vaccination and MS, adding new insights on their safety.

The knowledge of the immunisation status is crucial for the clinical practice in the management of the new disease modifying drugs (DMDs), and for the public health to establish the possible need of a vaccine campaign targeted to MS patients.

Conditions

• Multiple Sclerosis

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla

  collaborator OTHER

• San Luigi Gonzaga Hospital

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• Universita degli Studi di Catania

  collaborator OTHER

• Universita degli Studi di Genova

  collaborator OTHER

• San Camillo Hospital, Rome

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• University of Florence

  collaborator OTHER

• Istituto Neurologico Mediterraneo Neuromed S. R. L

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Maggiore Bellaria Hospital, Bologna

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Ospedale San Donato

  collaborator OTHER

• Ospedale San Giuseppe di Empoli

  collaborator OTHER

• Ospedale Livorno

  collaborator OTHER

• Ospedale Misericordia e Dolce

  collaborator OTHER

• Ospedale della Misericordia

  collaborator OTHER

• Ospedale San Jacopo

  collaborator UNKNOWN

• Ospedale Felice Lotti di Pontedera

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• Università degli Studi di Ferrara

  collaborator OTHER

• Monica Ulivelli

  lead OTHER

Principal Investigators

• Monica Ulivelli, researcher · University of Siena

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-20

Primary Completion

2023-01-31

Completion

2023-03-31

Countries

• Italy

Study Locations