Vaccine Exposure in Patients With MS

NCT03191669 | Completed

• 1 other identifier: 69HCL17_0169
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients exposed to seasonal flu vaccine in 2016-2017

  Two-weeks period in July 2017

Study Arms (1)

MS patients

Single group of patients with MS attending an outpatient MS clinic or hospitalization

Other: Auto-questionnaire

Interventions

Auto-questionnaire OTHER

Single Auto-questionnaire administered during or after a consultation/hospitalization

MS patients

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

patients with MS attending an outpatient MS clinic or hospitalization

You may qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

Hôpital Neurologique Pierre Wertheimer

Bron, 69500, France

Location

Service de Neurologie - Hôpital G. Montpied

Clermont-Ferrand, 63003, France

Location

Service de Neurologie - CHU de Grenoble

Grenoble, 38043, France

Location

Service de Neurologie - Hôpital Saint Joseph Saint Luc

Lyon, 69007, France

Location

Cabinet de Neurologie - Clinique de la Sauvegarde

Lyon, 69009, France

Location

Service de Neurologie - Hôpital Nord - CHU St Etienne

Saint-Etienne, 42055, France

Location

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

• Sandra VUKUSIC

  Hôpital Neurologique Pierre Wertheimer - GHE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 19, 2017
• Study Start: June 26, 2017
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: April 13, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)