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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014