Immune response to TBE vaccination
Conditions
Interventions
Trade Name: FSME-IMMUN Vuxen
Product Name: FSME-immun vuxen
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
Region Örebro län
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adults = 50 år or between 18-40 years ? Women and men ? Good health ? Written consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 diseas, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of whether a proposed extra dose of primary vaccination against TBE in healthy individuals = 50 years of age provides the same protection against TBE as the regular vaccination schedule in younger, 50 years and after the second vaccine dose in younger 50 years and after the second vaccine dose in younger <40 years and one month after the first booster dose after 5-12 months for both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Before and after the primary vaccination schedule (dose 3 for elderly> 50 years and dose 2 for younger 50 years and dose 2 for younger <40 years) and after booster vaccination after 5-12 months. Quantity of IL-2, INF? and IL-10 (possibly also IL-4, TNF, IL-1ß, IL-6) after antigen stimulation before and after the primary vaccination schedule and after booster vaccination after 5-12 months. | — |
Countries
Sweden
Contacts
Public ContactAnja Rosdahl
Region Örebro län
Outcome results
None listed