E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will investigate immunity against tick-borne encephalitis (TBE) following primary TBE vaccination in healthy volunteers 18-30 years or > 60 years who fulfill the local criteria for TBE vaccination (tick exposure possible). |
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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 | 10036897 |
E.1.2 | Term | Prophylactic vaccination |
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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 |
To determine whether and how age affects vaccine-induced immune responses, a vaccination trial in volunteer participants will be performed using a licensed vaccine for primary immunization to protect against TBE. The study will include two groups: 1) healthy young adults 18-30 years old and 2) older adults, 60 years or older. All study participants will be vaccinated with the licenced inactivated TBE vaccine (FSME-IMMUN). Vaccination efficacy will be monitored longitudinally by assessing TBE virus-specific antibody (TBEV-specific ELISA, TBEV-specific neutralization), TBE virus-specific B memory cell response (ELISpot) and TBE virus-specific T cell response (cytokine production). Vaccination efficacy will be compared among the two age groups one month after each vaccination and three months after the second and third vaccination, respectively. |
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E.2.2 | Secondary objectives of the trial |
Investigation of the properties of a new laboratory test to evaluate vaccine efficacy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age < 30 years or > 60 years Criteria or TBE-vaccination fulfilled (tick exposure possible) Healthy according to the questionaire (completed before screening) Capable to understand and sign informed consent form (based on the judgment of the study physician)
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E.4 | Principal exclusion criteria |
Previous vaccination against TBE or diseases caused by other flaviviruses (Japan B encephalitis, yellow fever) Contraindication for TBE vaccination (according to SmPC 2007) Immunodeficiency, history of autoimmune disease or current intake of immunemodulating drugs (corticosteroids) Past medical history and/or current treatment for chronic cardiac, pulmonary or kidney disease, previous stroke, epilepsy, Parkinson’s disease, dementia, marcoumar therapy Pregnancy or lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of TBEV-specific B memory cells measured by ELISpot one month after each and three months after second and third TBE vaccine administration in subjects < 30 versus > 60 years of age.
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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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Trial will be completed when the last participant has received 3 doses of FSME-IMMUN, 0.5 ml and has completed the last visit (which is 3 months after the third dose of TBE vaccination). Expected completion: 31.01.2010 |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |