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

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Registration Number: NCT02275741
• Lead Sponsor: Dr. med. Micha Loebermann

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-27
• Primary Completion: 2015-09
• Study Completion: 2016-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-25
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specific antibody response to vaccination	four weeks	Serum samples are evaluated before and 4 Weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Rostock; 🇩🇪 Rostock, Germany