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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Specific antibody response to vaccination | Serum samples are evaluated before and 4 Weeks after vaccination | four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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relapsing remitting multiple sclerosis
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| Name | Affiliation | Role |
|---|---|---|
| Uwe K Zettl, Prof. Dr. | University of Rostock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rostock | Rostock | 18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30044050 | Result | 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. | |
| 31919278 |
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Serum sample
| 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. |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D007252 | Influenza Vaccines |
| D022362 | Hepatitis A Vaccines |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
| D014761 | Viral Hepatitis Vaccines |
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