Rabies virus (inactivated) strain Flury LEP for Viral infections

Inclusion criteria

• {"criterion_text":"- Age between 18 and 40 years\n- Good health according to investigator\n- Willingness and ability to adhere to the study regimen\n- Able to provide informed consent\n- Naïve to rabies exposure or vaccination\n- Willing to comply to a follow-up of 5 years\n- Unlikely to require rabies PrEP in next 5 years"}

Exclusion criteria

• {"criterion_text":"- History of previous rabies vaccination\n- History of any neurological disorder including epilepsy\n- Pregnancy or breastfeeding during study visits in which the participant is vaccinated\n- Any current infectious disease other than seasonal cold\n- Bleeding disorders or use of anticoagulants\n- Suspected previous vaccination against rabies\n- Known or suspected severe allergy against egg protein\n- Known or suspected allergy against any of the other vaccine components\n- History of unusual or severe reactions to any previous vaccination\n- History of (pre)syncope associated with medical procedures involving n\n- Immunocompromized state due to illness or medication\n- Administration of plasma or blood products three months prior to inclusion\n- (hydroxy)chloroquine or mefloquine use"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 1 and day 8 after revaccination","definition_or_measurement_approach":"Rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies measured between day 1 and day 8 after revaccination (GMC of RVNA)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination.","definition_or_measurement_approach":"Proportion of subjects with rabies virus neutralizing antibody (RVNA) titer >0.5 IU/mL measured at the specified time points."}
• {"endpoint_text":"- Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D8 and D15 after the simulated post-exposure vaccination","definition_or_measurement_approach":"Proportion of subjects with RVNA titer >0.5 IU/mL measured at D1, D8 and D15 after simulated post-exposure vaccination."}
• {"endpoint_text":"- Percentage of subjects with RVNA titer >3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP.","definition_or_measurement_approach":"Proportion of subjects with RVNA titers exceeding 3 IU/mL and 5 IU/mL at day 8 after simulated post-exposure prophylaxis (PEP)."}
• {"endpoint_text":"- GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination","definition_or_measurement_approach":"Geometric mean concentrations (GMCs) of RVNA measured at the listed time points after primary vaccination and after simulated post-exposure vaccination."}

Netherlands

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

240

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands