Back to resultsHumoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
Primary Purpose
Tick-borne Encephalitis
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
TBE vaccination and influenza vaccination
Sponsored by
About this trial
This is an interventional basic science trial for Tick-borne Encephalitis focused on measuring low responsiveness after vaccination
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.
Sites / Locations
- Institute of Specific Prophylaxis and Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
TBE low responder
FSME responder
hepatitis B non-responder
Arm Description
Outcomes
Primary Outcome Measures
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Secondary Outcome Measures
Full Information
NCT ID
NCT00804219
First Posted
December 5, 2008
Last Updated
July 20, 2011
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00804219
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-borne Encephalitis
Keywords
low responsiveness after vaccination
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TBE low responder
Arm Type
Experimental
Arm Title
FSME responder
Arm Type
Experimental
Arm Title
hepatitis B non-responder
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
TBE vaccination and influenza vaccination
Other Intervention Name(s)
FSME-Immun ATC code: J07 BA1, Inflexal ATC code: J07 BB02
Intervention Description
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Primary Outcome Measure Information:
Title
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Time Frame
7 days after TBE-booster plus influenza vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wiedermann-Schmidt, MD, PhD
Organizational Affiliation
Institute of Specific Prophylaxis and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Specific Prophylaxis and Tropical Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
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