ClinicalTrials.gg
CompletedNCT00804219Updated Jul 22, 2011

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

A Phase 4 interventional study of TBE vaccination and influenza vaccination in Tick-borne Encephalitis, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-22.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tick-borne Encephalitis

Keywords

  • low responsiveness after vaccination
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

This study's enrollment of 67 is below the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults (≥18 years) of both sexes without upper age limit
  • Willingness to sign written form
  • Basic vaccination plus one booster (minimum) of TBE-vaccine,

Exclusion criteria

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 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 for the administration of the TBE- or influenza vaccine according to the manufactures information.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    TBE low responder

    Biological: TBE vaccination and influenza vaccination

  • Experimental
    FSME responder

    Biological: TBE vaccination and influenza vaccination

  • Experimental
    hepatitis B non-responder

    Biological: TBE vaccination and influenza vaccination

Interventions

  • BiologicalTBE vaccination and influenza vaccination

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

    Also known as: FSME-Immun ATC code: J07 BA1, Inflexal ATC code: J07 BB02

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What researchers measure

Primary outcomes

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

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

07

Study locations

1 site
  • Institute of Specific Prophylaxis and Tropical Medicine
    Vienna, 1090, Austria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2008, a primary completion of Nov 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2008
First posted
Dec 8, 2008
Start
Dec 2008
Primary completionActual
Nov 2010
CompletionActual
Nov 2010
Last update
Jul 22, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00804219
First posted
Dec 8, 2008
Start date
Dec 2008
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Jul 22, 2011

Study contacts

Ursula Wiedermann-Schmidt, MD, PhD
principal investigator · Institute of Specific Prophylaxis and Tropical Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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