rabies
Conditions
Interventions
Travellers will be randomized between standard 2-dose PrEP (D0, D7), single
dose PrEP (standard intramuscular dose or one-fifth fractional intradermal
dose) or no PrEP before travel. After 6 months,
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Travellers visiting the travel clinics of AMC, "Tropen Advies Centrum - Travel Clinic 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 Travelling for less than 8 weeks Expected time of departure >1 weeks Good health according to investigator Willingness and ability to adhere to the study regimen Able to provide informed consent
Exclusion criteria
Exclusion criteria: Previous vaccination against rabies vaccine Requirement for standard rabies PrEP according to the national guidelines 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 |
|---|---|
| The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 0 and day 7 after revaccination for the different study groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Risk perception, knowledge and health beliefs concerning animal bites, animal associated injuries and rabies Attitudes towards rabies vaccination Percentage of travellers with RVNA titer >0.5 IU/mL at day 0, 2 months, and six months after primary vaccination. Percentage of travellers with RVNA titers>0.5 IU/mL at day 3, after the simulated post-exposure vaccination. Percentage of travellers with RVNA titers>3 IU/mL, and percentage of travellers with RVNA titers >5 IU/mL at day 7 after simulated PEP. Which cellular and humoral immune responses are associated with an adequate anamnestic response after simulated post-exposure vaccination? 1. Is there a difference in cellular and humoral immune responses induced by the two immunization regimes? 2. Is there a difference in kinetics of the immune response during immunization? 3. Is adaptive and innate immune activation/ modulation during immunization related to a differential degree of antigen exposure during immunization and booster response after simulated PEP? Is there a set of biomarkers on transcriptional level that predicts an adequate anamnestic response? | — |
Countries
Netherlands
Outcome results
None listed