The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological defict of a distinct patient group or if it is a antigen-specific phenomenon. group1:TBE low-responder (neutralisation titer =1:10) group3:hepatits B non-responder MedDRA version: 9.1 Level: LLT Classification code 10039244 Term: Routine va
Conditions
Interventions
Trade Name: FSME-Immun®
Product Name: FSME-Immun
Pharmaceutical Form: Injection*
Other descriptive name: Tick-Borne Encephalitis Virus1,2 ( strain Neudörfl
Concentration unit: µg microgram(s)
Concentr
Sponsors
Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults (=18 years) of both sexes without upper age limit • Willingness to sign written informed consent form 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age: 37.9°C ) • Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study • Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study • History of autoimmune disease • drug addiction • plasma donators • administration of other vaccines 4 weeks before/after day 0 • Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period • Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses. • History of any malignant disease 5 years prior to the study entry • Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: cellular TBE Immunity (cytokine production) 7 days after TBE-booster vaccination plus influenza vaccination;Secondary Objective: antibody titers against TBE up to 6 months after TBE booster vaccination in low- and high-responders. cellular markers of low- and high-responders.;Primary end point(s): cellular TBE immunity (cytokine production) 7 days after TBE-booster vacconation plus influenza vaccination | — |
Countries
Austria
Outcome results
None listed