Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

Study Overview
=================
Brief Summary
-----------------
The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees. 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 deficit of a distinct patient group or if it is a antigen-specific phenomenon.

Official Title
-----------------
Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination

Conditions
-----------------
Tick-borne Encephalitis

Intervention / Treatment
-----------------
* Biological: TBE vaccination and influenza vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18 years) of both sexes without upper age limit Willingness to sign written informed consent form Basic vaccination plus one booster (minimum) of TBE-vaccine, Exclusion Criteria: Age: < 18 years Pregnancy or breast feeding Prior TBE infection 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBE low responder<br> | Biological: TBE vaccination and influenza vaccination<br>* FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x<br>* Other names: Inflexal ATC code: J07 BB02;|
| Experimental: FSME responder<br> | Biological: TBE vaccination and influenza vaccination<br>* FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x<br>* Other names: Inflexal ATC code: J07 BB02;|
| Experimental: hepatitis B non-responder<br> | Biological: TBE vaccination and influenza vaccination<br>* FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x<br>* Other names: Inflexal ATC code: J07 BB02;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination |  | 7 days after TBE-booster plus influenza vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low responsiveness after vaccination