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

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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