Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple Sclerosis
Conditions
Interventions
Trade Name: Revaxis
Product Name: Revaxis
Pharmaceutical Form: Injection*
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression. ; Secondary Objective: The change in the number of natural killer cells will be assessed, using CD3 and CD56 expression. Natural killer cells and peripheral blood mononuclear cells will be isolated and their cytokine expression will be analysed using flow cytometry. EDSS will be assessed by qualified assessors and any change will be calculated. Relapse rates will be compared. ;Primary end point(s): The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression. | — |
Countries
United Kingdom
Outcome results
None listed