Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis

NCT02275741 | Completed

• 1 other identifier: UMR-MS2012
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether prophylactic vaccines recommended are effective and safe in patients with multiple sclerosis(MS) under MS-specific therapy.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Vaccine; Antibody response; relaps rate; expanded disability status scale

Outcome Measures

Primary Outcomes (1)

• Specific antibody response to vaccination

  Serum samples are evaluated before and 4 Weeks after vaccination

  four weeks

Secondary Outcomes (1)

• MS relapse rate

  12 months

Interventions

prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal) BIOLOGICAL

Publically recommended protective vaccines in MS patients, vaccination applied according to the manufacturers description

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

relapsing remitting multiple sclerosis

You may qualify if:

• Established diagnosis of Multiple Sclerosis
• Age: 18 - 70 years
• Indication for vaccination (according to public recommendation)
• Written informed consent

You may not qualify if:

• Current relapse of MS
• Unstable disease
• Contraindication for vaccination (acute infection, fever, allergy to vaccine)
• Unable to comply with study procedures

Sponsors & Collaborators

• Dr. med. Micha Loebermann: lead

Study Sites (1)

University of Rostock

Rostock, 18057, Germany

Location

Related Publications (2)

• Metze C, Winkelmann A, Loebermann M, Hecker M, Schweiger B, Reisinger EC, Zettl UK. Immunogenicity and predictors of response to a single dose trivalent seasonal influenza vaccine in multiple sclerosis patients receiving disease-modifying therapies. CNS Neurosci Ther. 2019 Feb;25(2):245-254. doi: 10.1111/cns.13034. Epub 2018 Jul 25.

  PMID: 30044050 RESULT

• Winkelmann A, Metze C, Frimmel S, Reisinger EC, Zettl UK, Loebermann M. Tick-borne encephalitis vaccination in multiple sclerosis: A prospective, multicenter study. Neurol Neuroimmunol Neuroinflamm. 2020 Jan 9;7(2):e664. doi: 10.1212/NXI.0000000000000664. Print 2020 Jan.

  PMID: 31919278 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Tetanus Toxoid; Influenza Vaccines; Hepatitis A Vaccines; Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines; Viral Hepatitis Vaccines

Study Officials

• Uwe K Zettl, Prof. Dr.

  University of Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head, Department of Tropical Medicine an Infectious Diseases

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2016
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

DE (1)