Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
2 other identifiers
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 5, 2008
CompletedFirst Posted
Study publicly available on registry
December 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJuly 22, 2011
November 1, 2010
1.9 years
December 5, 2008
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
7 days after TBE-booster plus influenza vaccination
Study Arms (3)
TBE low responder
EXPERIMENTALFSME responder
EXPERIMENTALhepatitis B non-responder
EXPERIMENTALInterventions
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Specific Prophylaxis and Tropical Medicine
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ursula Wiedermann-Schmidt, MD, PhD
Institute of Specific Prophylaxis and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 5, 2008
First Posted
December 8, 2008
Study Start
December 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
July 22, 2011
Record last verified: 2010-11