E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immune response to TBE vaccination |
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E.1.1.1 | Medical condition in easily understood language |
Immune response to TBE vaccination |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
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 |
Evaluation of whether a proposed extra dose of primary vaccination against TBE in healthy individuals ≥ 50 years of age provides the same protection against TBE as the regular vaccination schedule in younger, <40 years, healthy individuals |
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E.2.2 | Secondary objectives of the trial |
Is the cellular immune response different in responders and non-responders before and after TBE vaccination?
Does the cellular and humoral immune response correspond when vaccinating against TBE?
Is there a difference in the cellular immune response between older (≥ 50 år) and younger (≥ 40 år) individuals after TBE vaccination?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults ≥ 50 år or between 18-40 years Women and men Good health Written consent to participate in the study |
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E.4 | Principal exclusion criteria |
Previous vaccination against TBE Previous TBE infection Allergy or hypersensitivity to any substance in the vaccine Previously known or suspected infection with Japanese encephalitis, Dengue virus, West Nile fever or Yellow fever Information on previous vaccination against Yellow fever or Japanese encephalitis Acute illness, eg fever with malaise Immunosuppression, due to medication or disease Previous treatment with Rituximab or equivalent Autoimmune diseas, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c < 6 %) Obesity, BMI > 40 Moderate to severe renal failure including hemodialysis, estimated GFR < 30. Blood transfusion or immunoglobulins <3 months ago Pregnancy Any other illness where the investigator consider the subject unsuitable for the study The study subject does not want to participate |
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E.5 End points |
E.5.1 | Primary end point(s) |
NT (neutralizing antibodies) one month after the third vaccine dose in elderly> 50 years and after the second vaccine dose in younger <40 years and one month after the first booster dose after 5-12 months for both groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after the third vaccine dose in elderly> 50 years and after the second vaccine dose in younger <40 years and one month after the first booster dose after 5-12 months for both groups. |
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E.5.2 | Secondary end point(s) |
Distribution of naïve and memory B and T cells before and after the primary vaccination schedule (dose 3 for elderly> 50 years and dose 2 for younger <40 years) and after booster vaccination after 5-12 months.
Quantity of IL-2, INFγ and IL-10 (possibly also IL-4, TNF, IL-1β, IL-6) after antigen stimulation before and after the primary vaccination schedule and after booster vaccination after 5-12 months. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before and after the primary vaccination schedule (dose 3 for elderly> 50 years and dose 2 for younger <40 years) and after booster vaccination after 5-12 months. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |