CompletedPhase 4

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

Austria67 participantsStarted 2008-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 7 days after TBE-booster plus influenza vaccination

Trial details

NCT IDNCT00804219

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Tick-borne Encephalitis trials