Characterization of Humoral and Cellular Immunity of Low and High-Responders After Tick-Borne Encephalitis (TBE) Vaccination - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00804219

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 IV

MedlinePlus related topics: Encephalitis Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Characterization of Humoral and Cellular Immunity of Low and High-Responders After TBE Vaccination

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 ]

Estimated Enrollment:	75
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TBE low responder: Experimental	Biological: TBE vaccination and influenza vaccination FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
FSME responder: Experimental	Biological: TBE vaccination and influenza vaccination FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
hepatitis B non-responder: Experimental	Biological: TBE vaccination and influenza vaccination FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

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

Contacts

Contact: Maria Paulke-Korinek, MD		maria.paulke-korinek@meduniwien.ac.at
Contact: Angelika Wagner, MD		angelika.wagner@meduniwien.ac.at

Locations

Austria
Institute of Specific Prophylaxis and Tropical Medicine	Recruiting
Vienna, Austria, 1090
Contact: Maria Paulke-Korinek, MD maria.paulke-korinek@meduniwien.ac.at
Sub-Investigator: Maria Paulke-Korinek, MD
Sub-Investigator: Angelika Wagner, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Ursula Wiedermann-Schmidt, MD, PhD

Institute of Specific Prophylaxis and Tropical Medicine

More Information

Responsible Party:	Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna ( Prof. Dr. Ursula Wiedermann-Schmidt )
Study ID Numbers:	FSME low-responder 1.1, EK Nr 474/2008
Study First Received:	December 5, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00804219
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

low responsiveness after vaccination

Study placed in the following topic categories:

Virus Diseases
Tick-borne encephalitis
Central Nervous System Infections
Central Nervous System Diseases
Arbovirus Infections

Brain Diseases
Tick-Borne Diseases
Encephalitis
Encephalitis, Tick-Borne

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009