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

Tick-borne Encephalitis Clinical Trial

Official title:

Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804219
• Other study ID #: FSME low-responder 1.1
• Secondary ID: EK Nr 474/2008
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2008
• Last updated: July 20, 2011
• Start date: December 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-borne Encephalitis

Intervention

Biological:
• TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

Locations

Country	Name	City	State
Austria	Institute of Specific Prophylaxis and Tropical Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination		7 days after TBE-booster plus influenza vaccination	No