Clinical trial NCT02275741: Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis
Official title: Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Vaccine
Antibody response
relaps rate
expanded disability status scale
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: relapsing remitting multiple sclerosis

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.

Eligibility 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

Primary outcomes:
measure: Specific antibody response to vaccination
timeFrame: four weeks
Secondary outcomes:
measure: MS relapse rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
Study officials:
affiliation: University of Rostock
name: Uwe K Zettl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.