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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00804219
First received: December 5, 2008
Last updated: July 20, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Tick-borne Encephalitis
Biological: TBE vaccination and influenza vaccination
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination [ Time Frame: 7 days after TBE-booster plus influenza vaccination ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TBE low responder Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02
Experimental: FSME responder Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02
Experimental: hepatitis B non-responder Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804219

Locations
Austria
Institute of Specific Prophylaxis and Tropical Medicine
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ursula Wiedermann-Schmidt, MD, PhD Institute of Specific Prophylaxis and Tropical Medicine
  More Information

No publications provided

Responsible Party: Prof. Dr. Ursula Wiedermann-Schmidt, Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00804219     History of Changes
Other Study ID Numbers: FSME low-responder 1.1, EK Nr 474/2008
Study First Received: December 5, 2008
Last Updated: July 20, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
low responsiveness after vaccination

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 22, 2014