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

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.

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Key information

Conditions

Tick-borne Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Tick-Borne Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Specific Prophylaxis and Tropical Medicine

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TBE vaccination and influenza vaccination

Biological

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

Primary outcomes

cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination

Time frame: 7 days after TBE-booster plus influenza vaccination

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Dec 8, 2008
Registry last updated: Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed