CompletedPhase 2/3

New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

Finland, Sweden250 participantsStarted 2015-01

Plain-language summary

The risk for tick borne encephalitis increases in Sweden. Together with an increased awareness of the possibility to acquire protection by vaccination, this has led to an increase in the number of doses of the vaccine distributed in Sweden each year - now being approximately 400.000. The first year, two doses with an interval of 1 month is recommended for the general population, followed by a third dose approximately one year later and an additional booster dose three years after the third. Preliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group. The investigators therefore aim to confirm results in a new study and to add a group with a double dose at day 0 and then a single dose at day 30 and 360

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: * Age 50 years or more (Control group 18 years) * generally healthy * no immunosuppressive condition * fertile women must use contraceptives Exclusion Criteria: * Previous TBE infection * Previously immunized with TBE vaccine * Anaphylactic reaction to egg protein * Any disease or therapy which might suppress the immune response * Vaccination should be delayed if a participant has fever

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

Serum concentration of neutralising antibodies against TBE one month after two or three doses.

Timeframe: 18 months after the first dose

Trial details

NCT IDNCT02318069

SponsorSormland County Council, Sweden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Tick-borne Encephalitis trials