Primary TBE Vaccination for the Elderly
- Conditions
- VaccineTick-borne Encephalitis
- Interventions
- Drug: FSME-IMMUN Vaccine
- Registration Number
- NCT04573205
- Lead Sponsor
- Region Örebro County
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Adults ≥ 50 years or between 18-40 years
- Man or woman
- God health
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description > 50 years FSME-IMMUN Vaccine Healthy individuals \> 50 years of age divided into age groups 50-59 years, 60-69 years and \>70 years, approximately 20 participants in each group. Vaccinated with 4 doses FSME immune Adult intramuscular injection according to the recommended primary vaccine Schedule in Sweden for individuals \> 50 years of age, at time 0, 1, 2 and 7 months. < 40 years FSME-IMMUN Vaccine Healthy individuals \< 40 years of age. Vaccinated with 3 doses FSME immune Adult intramuscular injection according to the standard recommended primary vaccine at time 0, 1, and 7 months.
- Primary Outcome Measures
Name Time Method Serological response to vaccination with TBE vaccine following primary vaccination NT measured 1 months after vaccination The proportion of individuals \> 50 years that achieves protective levels following the extra primary vaccine dose compared to the proportion of individuals tha achieve protective levels of neutralizing antibodies following the second vaccine dose in those \< 40 years.
Serological response to vaccination with TBE vaccine following the full vaccine scehdule NT measured 1 months after vaccination The proportion of individuals \> 50 years that achieves protective levels of neutralizing antibodies following the final primary schedule ( dose 4), compared to those \< 40 years ( 3 doses).
- Secondary Outcome Measures
Name Time Method Cellular immunity in young and elderly ( immune cell expression) Measured 7 days after vaccination T and B cell populations (flow cytometry) 7 days after TBE vaccination
Cellular immunity in young and elderly ( cytokine production) Measured 7 days after vaccination Cytokine production ( Luminex) 7 days after TBE vaccination
Trial Locations
- Locations (1)
Region Örebro Län
🇸🇪Örebro, Sweden