Healthy volunteers MedDRA version: 21.1 Level: LLT Classification code 10069589 Term: Rabies immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Rabipur
Product Name: Rabipur
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: Rabies vaccine
Other descriptive name: RABIES VIRUS (INACTIVATED
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years and =40 years • Good health according to investigator • Willingness and ability to adhere to the study regimen • Able to provide informed consent • Naïve to rabies exposure or vaccination • Willing to comply to a follow-up of 5 years • Unlikely to require rabies PrEP in next 5 years 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 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of previous rabies vaccination • Suspected previous vaccination against rabies • Known or suspected severe allergy against egg protein • Known or suspected allergy against any of the other vaccine components • History of unusual or severe reactions to any previous vaccination • History of (pre)syncope associated with medical procedures involving needles • Immunocompromized state due to illness or medication • Administration of plasma or blood products three months prior to inclusion • (hydroxy)chloroquine or mefloquine use • History of any neurological disorder including epilepsy • Pregnancy during study visits in which the participant is vaccinated • Breastfeeding during and up to 4 weeks after study visits in which the participant is vaccinated • Any current infectious disease other than seasonal cold • Bleeding disorders or use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the presence of a rapid and adequate anamnestic antibody response against rabies virus vaccine five years after primary vaccination with a single intramuscular dose (1.0 mL) of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 8 after a standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group who received primary vaccination with 2-dose PrEP. ;Secondary Objective: 1. To describe the kinetics of rabies virus neutralizing antibody levels in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up. 2. To describe the kinetics of rabies-specific memory B-cells in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up. ;Primary end point(s): The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of rabies neutralizing antibodies between day 1 and day 8 after revaccination.;Timepoint(s) of evaluation of this end point: 5 years after pre-exposure immunization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination. Percentage of subjects with RVNA titers>0.5 IU/mL at D1, D8 and D15, after the simulated post-exposure vaccination. Percentage of subjects with RVNA titers>3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP. 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. ;Timepoint(s) of evaluation of this end point: Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination. Percentage of subjects with RVNA titers>0.5 IU/mL at D1, D8 and D15, after the simulated post-exposure vaccination. Percentage of subjects with RVNA titers>3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP. 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. Some timepoints contain a margin in which it is acceptable that the study visit takes place. For D57/D64, this margin is -2 days and +7 days. For year 1, year 2 and year 5, this margin is -7 days and +7 days. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Infectious Diseases
Leiden University Medical Center
Outcome results
None listed