E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple Sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
to study the immune response to the vaccine |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |