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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275741
• Other study ID #: UMR-MS2012
• Status: Completed
• Start date: October 2009
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Biological:
• prophylactic 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

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
Dr. med. Micha Loebermann

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific antibody response to vaccination	Serum samples are evaluated before and 4 Weeks after vaccination	four weeks
Secondary	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