This study will investigate immunity against tick-borne encephalitis (TBE) following primary TBE vaccination in healthy volunteers 18-30 years or > 60 years who fulfill the local criteria for TBE vaccination (tick exposure possible). MedDRA version: 9.1 Level: LLT Classification code 10036897 Term: Prophylactic vaccination
Conditions
Interventions
Trade Name: FSME-IMMUN, 0.5 ml
Pharmaceutical Form: Suspension for injection
Other descriptive name: TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED)
Concentration unit: µg microgram(s)
Concentration typ
Sponsors
Clinical Institute of Virology, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 60 years Criteria or TBE-vaccination fulfilled (tick exposure possible) Healthy according to the questionaire (completed before screening) Capable to understand and sign informed consent form (based on the judgment of the study physician) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous vaccination against TBE or diseases caused by other flaviviruses (Japan B encephalitis, yellow fever) Contraindication for TBE vaccination (according to SmPC 2007) Immunodeficiency, history of autoimmune disease or current intake of immunemodulating drugs (corticosteroids) Past medical history and/or current treatment for chronic cardiac, pulmonary or kidney disease, previous stroke, epilepsy, Parkinson’s disease, dementia, marcoumar therapy Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether and how age affects vaccine-induced immune responses, a vaccination trial in volunteer participants will be performed using a licensed vaccine for primary immunization to protect against TBE. The study will include two groups: 1) healthy young adults 18-30 years old and 2) older adults, 60 years or older. All study participants will be vaccinated with the licenced inactivated TBE vaccine (FSME-IMMUN). Vaccination efficacy will be monitored longitudinally by assessing TBE virus-specific antibody (TBEV-specific ELISA, TBEV-specific neutralization), TBE virus-specific B memory cell response (ELISpot) and TBE virus-specific T cell response (cytokine production). Vaccination efficacy will be compared among the two age groups one month after each vaccination and three months after the second and third vaccination, respectively.;Secondary Objective: Investigation of the properties of a new laboratory test to evaluate vaccine efficacy.;Primary end point(s): Frequency of TBEV-specific B memory cells measured by ELISpot one month after each and three months after second and third TBE vaccine administration in subjects 60 years of age. | — |
Countries
Austria
Outcome results
None listed