Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Vaccine, Antibody response, relaps rate, expanded disability status scale
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.
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.
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
Sponsors
Dr. med. Micha Loebermann
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specific antibody response to vaccination | four weeks | Serum samples are evaluated before and 4 Weeks after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MS relapse rate | 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. |
Countries
Germany
Outcome results
None listed