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

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ClinicalTrials.gov Identifier: NCT02275741
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. med. Micha Loebermann, University of Rostock

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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Biological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)

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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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis
Study Start Date : October 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: prophylactic 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


Primary Outcome Measures :
  1. Specific antibody response to vaccination [ Time Frame: four weeks ]
    Serum samples are evaluated before and 4 Weeks after vaccination


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Serum sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
relapsing remitting multiple sclerosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275741


Locations
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Germany
University of Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Dr. med. Micha Loebermann
Investigators
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Principal Investigator: Uwe K Zettl, Prof. Dr. University of Rostock

Publications of Results:
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Responsible Party: Dr. med. Micha Loebermann, Deputy Head, Department of Tropical Medicine an Infectious Diseases, University of Rostock
ClinicalTrials.gov Identifier: NCT02275741     History of Changes
Other Study ID Numbers: UMR-MS2012
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Keywords provided by Dr. med. Micha Loebermann, University of Rostock:
Vaccine
Antibody response
relaps rate
expanded disability status scale
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs