The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple Sclerosis; Multiple sclerosis

• Registration Number: EUCTR2007-001496-11-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Study Completion: 2013-06-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Clinically definite multiple sclerosis
Male or female subjects
18-65 years of age inclusive
Females who are sexually active taking effective contraception measures
Subjects must be able and willing to give informed consent, thereby excluding patients who are unable to understand, retain and weigh information given regarding the trial and use it to make an informed decision concerning their participation in the trial. By its nature, as we wish all subjects to give informed consent, it will exclude those who are unable to do this, either by virtue of language, learning disability or mental illness – but ethically and for safety reasons it would be inappropriate to include them in such a trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known allergy to any of the components of the vaccine Other history of allergy including seafood, hives, moderate to severe hayfever
Moderate to severe bronchial asthma
Patients taking beta blockers
Pregnancy or lactating females
Currently or in the previous six months taking immunomodulatory therapy (including but not limited to beta interferon, glatiramer acetate, mitoxantrone)
Any known serious systemic illness (cardiovascular / respiratory / renal / gastrointestinal / hepatic / any malignancy) apart from multiple sclerosis
Unable to tolerate venepuncture or intramuscular vaccination
Any medical, psychiatric or other condition that could result in a subject being unable to give fully informed consent or to comply with the protocol requirements
Any other medical or psychiatric condition which, in the opinion of the Investigator, makes the subject an unsuitable participant in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression. ;<br> Secondary Objective: The change in the number of natural killer cells will be assessed, using CD3 and CD56 expression.<br> Natural killer cells and peripheral blood mononuclear cells will be isolated and their cytokine expression will be analysed using flow cytometry.<br> EDSS will be assessed by qualified assessors and any change will be calculated. Relapse rates will be compared.<br><br> ;Primary end point(s): The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression.