Rabies
Conditions
Interventions
- Study group A – one single intramuscular dose (1 mL) of rabies vaccine (D1) - Study group B – standard three-dose (1 mL) intramuscular PrEP vaccination (D1, D8, D22)
Sponsors
Leiden University Medical Center (LUMC), Department of Infectious Diseases
Bavarian Nordic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age =18 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
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 or breastfeeding • Any current infectious disease other than seasonal cold • Bleeding disorders or use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of increase of GMC of RVNA between day 1 and day 8 after simulated PEP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D78, 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 D78, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination. | — |
Contacts
Public ContactDr. J.A. Vlot
Leiden University Medical Center (LUMC)
Outcome results
None listed