Immunisation Status and Safety of Vaccines in Italian MS Patients

NCT04300868 | Unknown

• 1 other identifier: 2019/S/2
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immunisation status; vaccine safety; vaccination

Outcome Measures

Primary Outcomes (1)

• prevalence of MS patients susceptible to infections

  prevalence of patients unvaccinated or never exposed to natural infections, which can represent a problem in case of administration of immunosuppresive drugs.

  december 2021

Secondary Outcomes (1)

• safety of vaccination in MS patients

  december 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relapsing remitting (RR)-MS patients consecutively diagnosed from January 2011 to December 2020 will be enrolled in the study upon informed written consent. The choice of January 2011 is suggested by the need to apply the 2010 Polman's diagnostic criteria for MS \[Polman 2011\] in order to ensure most homogeneous diagnoses across patients. Both for retrospective and prospective phase, each Center will identify, through clinical records, newly diagnosed MS patients in the considered period and consistently followed in the Center, and the enrolment will be made during routine ambulatory visits.

You may qualify if:

• diagnosis of RR-MS according to the 2010 Polman's diagnostic criteria \[Polman 2011\] or the 2017 revision of the McDonald criteria for the prospective cohort \[Thompson 2018\]
• written informed consent must be obtained before the enrolment

You may not qualify if:

• clinically isolated syndrome (CIS) and progressive MS forms
• unavailability or unreliability of medical records

Sponsors & Collaborators

• Monica Ulivelli: lead
• Fondazione Italiana Sclerosi Multipla: collaborator
• San Luigi Gonzaga Hospital: collaborator
• University of Roma La Sapienza: collaborator
• Universita degli Studi di Catania: collaborator
• Universita degli Studi di Genova: collaborator
• San Camillo Hospital, Rome: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• University of Florence: collaborator
• Istituto Neurologico Mediterraneo Neuromed S. R. L: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Maggiore Bellaria Hospital, Bologna: collaborator
• Federico II University: collaborator
• Ospedale San Donato: collaborator
• Ospedale San Giuseppe di Empoli: collaborator
• Ospedale Livorno: collaborator
• Ospedale Misericordia e Dolce: collaborator
• Ospedale della Misericordia: collaborator
• Ospedale San Jacopo: collaborator
• Ospedale Felice Lotti di Pontedera: collaborator
• Campus Bio-Medico University: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

university of Siena

Siena, SI, 53100, Italy

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Monica Ulivelli, researcher

  University of Siena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Ulivelli, researcher

CONTACT

0577585401; ulivelli@unisi.it

Daiana Bezzini, PhD

CONTACT

0577234517; daiana.bezzini@unisi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 20, 2019
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

IT (1)