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
|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)|
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|
|Actual Enrollment :||226 participants|
|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|
- 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
- Specific antibody response to vaccination [ Time Frame: four weeks ]Serum samples are evaluated before and 4 Weeks after vaccination
- 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
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
|University of Rostock|
|Rostock, Germany, 18057|
|Principal Investigator:||Uwe K Zettl, Prof. Dr.||University of Rostock|