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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Tick-borne Encephalitis

Treatments: Biological: TBE vaccination and influenza vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT00804219

FSME low-responder 1.1

EK Nr 474/2008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 3 patient groups

TBE low responder

Experimental group

Treatment:

Biological: TBE vaccination and influenza vaccination

FSME responder

Experimental group

Treatment:

Biological: TBE vaccination and influenza vaccination

hepatitis B non-responder

Experimental group

Treatment:

Biological: TBE vaccination and influenza vaccination