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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rostock

Rostock, 18057, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Specific antibody response to vaccination

Time frame: four weeks

Serum samples are evaluated before and 4 Weeks after vaccination

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dr. med. Micha Loebermann

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2016
First posted: Oct 27, 2014
Registry last updated: Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed