Clinical trial NCT04573205: Primary TBE Vaccination for the Elderly
Official title: Primary TBE Vaccination for the Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Tick-borne Encephalitis
Vaccine
Keywords: Elderly
Tick-borne Encephalitis
Vaccine
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Serological response to vaccination with TBE vaccine following primary vaccination
timeFrame: NT measured 1 months after vaccination
measure: Serological response to vaccination with TBE vaccine following the full vaccine scehdule
timeFrame: NT measured 1 months after vaccination
Secondary outcomes:
measure: Cellular immunity in young and elderly ( immune cell expression)
timeFrame: Measured 7 days after vaccination
measure: Cellular immunity in young and elderly ( cytokine production)
timeFrame: Measured 7 days after vaccination
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Region Örebro Län
Study officials:
References:
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