Brief Title
Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
Official Title
Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Condition
Tick-borne Encephalitis
Intervention
TBE vaccination and influenza vaccination
Study Arms / Comparison Groups
TBE low responder
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
67
Start Date
December 2008
Completion Date
November 2010
Primary Completion Date
November 2010
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ursula Wiedermann-Schmidt, MD, PhD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00804219
Organization ID
FSME low-responder 1.1
Secondary IDs
EK Nr 474/2008
Study Sponsor
Medical University of Vienna
Study Sponsor
Ursula Wiedermann-Schmidt, MD, PhD, Principal Investigator, Institute of Specific Prophylaxis and Tropical Medicine
Verification Date
November 2010