Vaccine Exposure in Patients With MS

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Auto-questionnaire

• Registration Number: NCT03191669
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet.

Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS.

Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France).

Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period.

Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-06-26
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Multiple sclerosis according to MacDonald 2010 criteria
• Age 18 and more

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MS patients	Auto-questionnaire	Single group of patients with MS attending an outpatient MS clinic or hospitalization

Primary Outcome Measures

Name	Time	Method
Percentage of patients exposed to seasonal flu vaccine in 2016-2017	Two-weeks period in July 2017

Trial Locations

Locations (6)

Hôpital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Service de Neurologie - CHU de Grenoble; 🇫🇷 Grenoble, France

Cabinet de Neurologie - Clinique de la Sauvegarde; 🇫🇷 Lyon, France

Service de Neurologie - Hôpital G. Montpied; 🇫🇷 Clermont-Ferrand, France

Service de Neurologie - Hôpital Nord - CHU St Etienne; 🇫🇷 Saint-Étienne, France

Service de Neurologie - Hôpital Saint Joseph Saint Luc; 🇫🇷 Lyon, France