Tick-borne encephalitis virus Neudoerfl strain adsorbed on aluminium hydroxide, hydrated produced in chick embryo cells for Tick-borne encephalitis

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the clinical trial."}
• {"criterion_text":"- Male and female research participants above or equal to 18 years of age."}

Exclusion criteria

• {"criterion_text":"- Women with ongoing pregnancy or breast feeding without prior history of hospitalization for TBE or vaccination against TBEV."}
• {"criterion_text":"- Inability or unwillingness to provide informed consent or abide by the requirements of the clinical trial."}
• {"criterion_text":"- Evidence of allergy or other known adverse reaction to components are part of the TBE vaccine (FSME-IMMUN Vuxen) for unvaccinated participants planning to undergo vaccination against TBEV in the clinical trial."}
• {"criterion_text":"- Having a bleeding disorder or receiving preventive anticoagulation therapy which prevents the vaccine being administered intramuscularly, for individuals without prior history of hospitalization for TBE or prior vaccination against TBEV."}

Primary endpoints

• {"endpoint_text":"- Concentrations of cytokines detected using our novel rapid release assay (T-cell assay) for TBE in relation to antibody responses (B-cell assays) as measured by commercially available assays.","definition_or_measurement_approach":"Cytokine concentrations measured using the novel cytokine release (T-cell) assay; compared to antibody responses measured by commercially available IgM assays (Euroimmun and ReaScan) and/or quantitative IgG assay (Euroimmun)."}

Secondary endpoints

• {"endpoint_text":"- The duration of detectable T- and B-cell immune responses directed against TBEV after infection with TBE.","definition_or_measurement_approach":"Duration assessed by detection of T- and B-cell responses using the T-cell cytokine release assay and commercially available antibody assays."}
• {"endpoint_text":"- The duration of detectable T- and B-cell immune responses directed against TBEV after vaccination against TBE.","definition_or_measurement_approach":"Duration assessed by detection of T- and B-cell responses using the T-cell cytokine release assay and commercially available antibody assays."}
• {"endpoint_text":"- Are cross-reactive T- and B-cell immune responses directed against TBEV detectable after prior vaccination against other flaviviruses, e.g., Yellow Fever and Japanese Encephalitis, and if so, are these responses transient or persistent?","definition_or_measurement_approach":"Cross-reactivity assessed by measuring T- and B-cell responses after prior vaccination against other flaviviruses (e.g., Yellow Fever, Japanese Encephalitis) using the T-cell assay and antibody assays; temporal persistence evaluated."}

Sweden

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

07-02-2025

Processing Time Days

287

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden