Status:
COMPLETED
Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
Lead Sponsor:
Medical University of Vienna
Conditions:
Tick-borne Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 projec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00804219
Start Date
December 1 2008
End Date
November 1 2010
Last Update
July 22 2011
Active Locations (1)
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1
Institute of Specific Prophylaxis and Tropical Medicine
Vienna, Vienna, Austria, 1090