The study is exploring the cross neutralizing potential of human sera after primary immunization with FSME-IMMUN 0.5 ml or Encepur 0.5 ml against different strains within the same TBEV subtype, other TBEV subtypes, closely related viruses of the TBEV serogroup, and also more distantly related flaviviruses, based on the use of a hybrid virus assay platform
Conditions
Interventions
Trade Name: FSME-IMMUN 0,5 ml ®
Product Name: FSME-IMMUN 0.5ml ®
Pharmaceutical Form: Injection
INN or Proposed INN: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN
Other descriptive na
Sponsors
Medical University of Vienna, ISPTM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects will be eligible for participation in this study if they: Are healthy adults, aged >18 – =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be eligible to participate in this study if any of the following apply: Age 50 years History of vaccination against WNV, YFV, JE, Dengue or TBE History of a WNV, YFV, JE, Dengue or TBE infection Contraindication against vaccination with a tick-borne encephalitis vaccine, according to the respective SmPC Pregnancy or breast feeding Medication treatment influencing the immune system: e.g. systemic corticoids (> 20mg/d), immunotherapy (e.g. allergy), chemotherapy, immunosuppressive drugs within 4 weeks of study start or during the study Other vaccinations within 4 weeks of study start till 4 weeks after the second vaccination and 4 weeks before till 4 weeks after the third vaccination Any surgery, requiring hospitalization, within 4 weeks of study start and/or planned surgery during the study Severe medical condition requiring hospitalization within 3 months of study start Any current malignancy within 5 years of study start Autoimmune disease² Progressive, unstable or uncontrolled clinical conditions Abuse disorder (abuse of drug, alcohol, chemical or psychoactive substance) or mental disability Receipt of plasma, blood or blood products, as well as immunoglobulins within 3 months of study start and during the study Plasma, blood and blood product donation within 3 months of study start and during the study Concomitant participation in another clinical trial Employee of the study center with direct study involvement or family member of the Investigator or employee with direct study involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the cross neutralizing potential of human sera after primary immunization with FSME-IMMUN 0.5 ml and Encepur 0.5 ml against different strains within the same TBEV subtype, other TBEV subtypes, closely related viruses of the TBEV serogroup, and also more distantly related flaviviruses, based on the use of a hybrid virus assay platform.;Secondary Objective: To investigate the impact of amino acid differences in the E proteins of the two vaccine virus strains (Neudörfl [Nd] and Karlsruhe 23 [K23]) on their ability to induce cross-neutralizing antibody responses against different wild type flaviviruses. To investigate the cellular immune response to vaccination by determination of cytokines after in-vitro stimulation of PBMCs using both antigens, Nd and K23, and evaluation of CD-surface marker expression on lymphocytes. ;Primary end point(s): The primary endpoint is the ratio between the neutralizing titres against the homologous and heterologous antigens measured 28-35 days after the second to that before the first vaccination (against K23 or Nd, respectively);Timepoint(s) of evaluation of this end point: The primary endpoint is the ratio between the neutralizing titres against the homologous and heterologous antigens measured 28-35 days after the second to that before the first vaccination (against K23 or Nd, respectively) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Seroconversion rates, NT titres =10 (NT titre measured using the hybrid neutralization assay platform) 14 (+-2) days after the second vaccination Seroconversion rates, NT titres =10 (NT titre measured using the hybrid neutralization assay platform) 28-35 days after the second and third vaccination, respectively. Concentration of cross-neutralizing antibodies against different wild type flaviviruses . Cytokine concentrations in Ag stimulated PBMCs (using both – Nd and K23 - antigens), as well as the lymphocyte fractions 28-35 days after the second and third vaccination, respectively .;Timepoint(s) of evaluation of this end point: Seroconversion rates, NT titres =10 (NT titre measured using the hybrid neutralization assay platform) 14 (+-2) days after the second vaccination Seroconversion rates, NT titres =10 (NT titre measured using the hybrid neutralization assay platform) 28-35 days after the second and third vaccination, respectively. Concentration of cross-neutralizing antibodies against different wild type flaviviruses . Cytokine concentrations in Ag stimulated PBMCs (using both – Nd and K23 - antigens), as well as the lymphocyte fractions 28-35 days after the second and third vaccination, respectively . | — |
Countries
Austria
Contacts
Public ContactStudy coordination
Medical University of Vienna, ISPTM
Outcome results
None listed