Characterisation of humoral and cellular immunity of low- and high-responder after TBE vaccinatio

Conditions: 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)group2:TBE responder (neutralisation titer >=1:10)group3:hepatits B non-responder
MedDRA version: 9.1Level: LLTClassification code 10039244Term: Routine vaccination

Registration Number: EUCTR2008-005800-24-AT

Lead Sponsor: Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

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

•Age: < 18 years
•Pregnancy or breast feeding
•prior TBE infection
•
•Acute infection at day of inclusion (day 0) (body temperature > 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures