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 range18 Years

SexALL

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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

What they're measuring

Serological response to vaccination with TBE vaccine following primary vaccination

Timeframe: NT measured 1 months after vaccination

Serological response to vaccination with TBE vaccine following the full vaccine scehdule

Timeframe: NT measured 1 months after vaccination

Trial details

NCT IDNCT04573205

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

Anja Rosdahl

+46196021157 anja.rosdahl@regionorebrolan.se