E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Studies have shown that obesity has a direct effect on the immune system and leads to immunosuppression, which leads to a susceptibility to infection. The aim of this study is to clarify if a modification of vaccination schedules or a change of booster intervals is necessary for obese people. Furthermore this study will increase our understanding of the influence of obesity on different components of the immune system, as well as on the quality and quantity of the immune responses. |
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E.1.1.1 | Medical condition in easily understood language |
Obese people have an altered immune responsiveness. We investigate whether this influences immune responses to booster vaccinations and if a modification of vaccination schedules is needed. |
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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 |
Humoral immunity, based on TBE Neutralisationtest-Titers one month +/- 7 days after booster |
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E.2.2 | Secondary objectives of the trial |
TBE-titer course, cellular immune responses |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• willingness to sign written informed consent form • completed primary TBE immunization and at least 1 booster vaccination • participants of both sexes between 18 and 60 years of age
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E.4 | Principal exclusion criteria |
• age < 18 and > 60 years • BMI 25-30 • previous TBE infection • pregnancy or breast feeding • acute infection on day of inclusion (day 0) or at visit 5 (36 months), body temperature > 37,9°C • concomitant medications: systemic cortison therapy, chemotherapy, immunotherapy (allergy) immunsuppressive therapy 4 weeks prior or during the study •administration of other vaccines 4 weeks before/after day 0 •planned surgery within 2 weeks before/after TBE booster •any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions •malignant diseases within 5 years prior to the study •autoimmune diseases •kidney insufficiency, dialysis •drug addiction •plasma donor •receipt of blood transfusions or immunoglobulins within 3 months prior to study entry / within 3 months prior to visit 5 •Severe disease with hospitalization or surgery 3 months before or during the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Humoral immunity, based on TBE Neutralisationtest-Titers |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month +/- 7 days after booster |
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E.5.2 | Secondary end point(s) |
TBE-titer course, cellular immune responses |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
TBE-titer course - titer evaluation before booster until 3 years after booster vaccination cellular immune response - evaluated before and 1 week after booster vaccination |
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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 | 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 |
Immunogenicity one month after vaccination. |
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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 | No |
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 | 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 | No |
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.8.5 | 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 | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |