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CompletedNCT02275741Updated Nov 27, 2018

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

An observational study in Multiple Sclerosis, Relapsing-Remitting, sponsored by Dr. med. Micha Loebermann. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-27.

Sponsored by Dr. med. Micha Loebermann · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
226
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the detailed description

Protective vaccines against communicable diseases are of major importance in patients with autoimmune diseases or impaired immune response. In patients with multiple sclerosis bacterial or viral infections may lead to disease progression and vaccines can protect from these infections and prevent disease progression. Fear of possible side effects of vaccines have led to a general restraint regarding vaccination of patients with MS. However, previous studies have not shown an increased risk of disease progression following Hepatitis B vaccination and even a reduced progression rate in relapsing-remitting MS after tetanus/diphtheria vaccination.

Various disease modifying treatments (DMT) are available for MS, most of these therapies lead to an impairment of the immune system affecting the immune response to vaccination. Additionally, live attenuated vaccines may lead to severe side-effects if used in patients under DMT treatment. Testing immune response after vaccination may be prudent in subjects undergoing DMT to assure vaccination success since only a limited number of studies have investigated immune response after vaccination in patients with MS undergoing DMT.

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Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting

Keywords

  • Vaccine
  • Antibody response
  • relaps rate
  • expanded disability status scale
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 226 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Dr. med. Micha Loebermann as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

relapsing remitting multiple sclerosis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
226 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

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

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

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What researchers measure

Primary outcomes

  1. Specific antibody response to vaccination

    Serum samples are evaluated before and 4 Weeks after vaccination

    Time frame: four weeks

Secondary outcomes

  1. MS relapse rate

    Course of MS is evaluated by relapse rate and EDSS (expanded disability status scale) is evaluated prior to and at month 6 and 12 after intervention.

    Time frame: 12 months

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Study locations

1 site
  • University of Rostock
    Rostock, 18057, Germany
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References and documents

Publications

  • 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. PubMed 30044050 ↗
  • 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. PubMed 31919278 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02275741
Lead sponsor
Dr. med. Micha Loebermann
Responsible party
Dr. med. Micha Loebermann (Deputy Head, Department of Tropical Medicine an Infectious Diseases, University of Rostock) — Sponsor-investigator
First posted
Oct 27, 2014
Start date
Oct 2009
Primary completion
Sep 2015
Completion
Nov 2016
Last update
Nov 27, 2018

Study contacts

Uwe K Zettl, Prof. Dr.
principal investigator · University of Rostock

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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