TBE vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.
Conditions
Sponsors
Institute of Specific Prophylaxis and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • completed primary TBE immunization + at least one booster immunization • adults of both sexes between 18 and 60 years of age • 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 116 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • age 60 years • proir TBE infection • pregnancy and breast feeding • acute infection on day of inclusion (day 0), (body temperature > 37,9°C) • concomitant medications: systemic cortison therapy, chemotherapy, immunesuppressive therapy 4 weeks prior to or during study • administration of other vaccines 4 weeks before/after day 0 • planned surgery within 2 weeks before/after TBE booster vacciantion • spezific immunotherapy (Hypo-/Desensibilisierung) 14 days before/after vaccination • any contraindication to adminstration of FSME-Immun® vaccine according to manufacturer's instructions • history of malignant disease within the last 5 years • autoimmune diseases • drug addictions • plasma donors • receipt of blood transfusions or immuno globulins within 3 month before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Humoral immunity, based on TBE Neutralisationtest titer one month +/- 7 days after booster;Secondary Objective: Cellular immune response, TBE titer course;Primary end point(s): Humoral immunity, based on TBE Neutralisationtest titer ;Timepoint(s) of evaluation of this end point: One month +/- 7 days after booster | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cellular immune response, TBE titer course;Timepoint(s) of evaluation of this end point: Cellular immune response - evaluated one week after booster vaccination TBE titer course - titer evaluation before until 6 month after booster vacciantion | — |
Countries
Austria
Contacts
Public ContactISPTM, Clinical Trials Information
Institute of Specific Prophylaxis and Tropical Medicine
Outcome results
None listed