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

November 25, 2018 updated by: Dr. med. Micha Loebermann
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

relapsing remitting multiple sclerosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific antibody response to vaccination
Time Frame: four weeks
Serum samples are evaluated before and 4 Weeks after vaccination
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MS relapse rate
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. med. Micha Loebermann

Investigators

  • Principal Investigator: Uwe K Zettl, Prof. Dr., University of Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMR-MS2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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