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

Phase 4

Completed

• Conditions: Tick-borne Encephalitis
• Interventions: Biological: TBE vaccination and influenza vaccination

• Registration Number: NCT00804219
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBE low responder	TBE vaccination and influenza vaccination	-
FSME responder	TBE vaccination and influenza vaccination	-
hepatitis B non-responder	TBE vaccination and influenza vaccination	-

Primary Outcome Measures

Name	Time	Method
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination	7 days after TBE-booster plus influenza vaccination

Trial Locations

Locations (1)

Institute of Specific Prophylaxis and Tropical Medicine; 🇦🇹 Vienna, Austria