Primary TBE Vaccination for the Elderly (NCT04573205) | Clinical Trial Compass
UnknownPhase 4
Primary TBE Vaccination for the Elderly
Sweden90 participantsStarted 2024-01
Plain-language summary
Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals \> 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those \> 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.
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 ≥ 50 years or between 18-40 years
* Man or woman
* God health
* Written informed consent
Exclusion Criteria:
* Previous vaccination against TBE
* Previous TBE infection
* Allergy or hypersensitivity to any substance in the vaccine
* Previously known or suspected infection with Japanese encephalitis, Dengue virus, West Nile fever or Yellow fever
* Information on previous vaccination against Yellow fever or Japanese encephalitis
* Acute illness, eg fever with malaise
* Immunosuppression, due to medication or disease
* Previous treatment with Rituximab or equivalent
* Autoimmune disease, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c \< 6 %)
* Obesity, BMI \> 40
* Moderate to severe renal failure including hemodialysis, estimated GFR \< 30.
* Blood transfusion or immunoglobulins \<3 months ago
* Pregnancy
* Any other illness where the investigator consider the subject unsuitable for the study
* The study subject does not want to participate
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
1
Serological response to vaccination with TBE vaccine following primary vaccination
Timeframe: NT measured 1 months after vaccination
2
Serological response to vaccination with TBE vaccine following the full vaccine scehdule