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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804219

Enrollment

Registered

2008-12-08

Start date

2008-12-31

Completion date

2010-11-30

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-borne Encephalitis

Keywords

low responsiveness after 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.

Interventions

BIOLOGICALTBE vaccination and influenza vaccination

FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026