healthy volunteer MedDRA version: 20.0 Level: LLT Classification code 10069589 Term: Rabies immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: rabipur
Product Name: Rabipur
Product Code: RVG 29095
Pharmaceutical Form: Lyophilisate and solvent for suspension for injection
INN or Proposed INN: Rabipur
Current Sponsor code: RVG 2909
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Travellers visiting the travel clinics of AMC, Harbour Hospital and LUMC will be invited to participate in this study. In order to be eligible to participate in this study, a subject must meet all of the following criteria: Age =18 years Expected time of departure >1 weeks Travelling for less than 8 weeks Good health according to investigator Willingness and ability to adhere to the study regimen Able to provide informed consent 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 264 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104
Exclusion criteria
Exclusion criteria: History of previous rabies vaccination Suspected previous vaccination against rabies Requirement for standard rabies PrEP according to the national guidelines Known or 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 or breastfeeding Any current infectious disease other than seasonal cold Bleeding disorders or use of anticoagulants Temporary exclusion criterion for vaccination: body temperature = 38.5°C or acute illness will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the presence of rapid and adequate anamnestic antibody response against rabies virus at six months after primary vaccination with a single intramuscular dose (1.0 mL) or one-fifth fractional intradermal dose of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 7, after a standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group with 2-dose PrEP. ;Secondary Objective: To determine health beliefs, knowledge and risk perception on animal bites and rabies, and attitude towards vaccination in these travellers before and after travel ;Primary end point(s): Rate of increase of GMC of RVNA between day 0 and day 7 after simulated PEP ;Timepoint(s) of evaluation of this end point: day 0 and day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of travellers with RVNA titer >0.5 IU/mL at day 0, six months after primary vaccination Percentage of travellers with RVNA titer>0.5 IU/mL at day 3, after the simulated post-exposure vaccination GMC of RVNA at 0, day 56-63, and 6 months after a single intramuscular dose of rabies vaccine GMC of RVNA at 0, day 56-63, and 6 months after a two-site intradermal one-fifth fractional doses of rabies vaccine GMC of RVNA at 0, day 63-70 and 6 months after standard PrEP with 2 intramuscular doses of rabies vaccine GMC of RVNA at day 0, day 3, day 7 and day 21 after the simulated post-exposure vaccination Knowledge, belief and risk perception about animal bites and rabies vaccination, before and after travel Percentage of travellers with animal contact during stay abroad Type of animal and type of contact (licking, scratching or biting) Measures taken after animal contact during travel Percentage of travellers who applied wound care after animal contact Percentage of travellers who started appropriate PEP after animal contact ;Timepoint(s) of evaluation of this end point: Day 0, Day 3, Day 7, Day 56-63/63-70, month 6, month 6 + 3 days, month 6 + 7 days, months 6 + 21 days | — |
Countries
Netherlands
Contacts
Public ContactDepartment Infectious Diseases
Leiden University Medical Center
Outcome results
None listed