Status:
UNKNOWN
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
Lead Sponsor:
Leiden University Medical Center
Conditions:
Rabies Pre-exposure Prophylaxis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
Exclusion
- Known or suspected previous vaccination against rabies
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Immunocompromized state due to illness or medication
- Administration of plasma or blood products three months prior to inclusion in the study
- (hydroxy)chloroquine or mefloquine use
- History of any neurological disorder including epilepsy or febrile seizures
- Pregnancy or breastfeeding
- Any current infectious disease other than seasonal cold
- Bleeding disorders or use of anticoagulants
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02276625
Start Date
October 1 2014
End Date
February 1 2016
Last Update
October 28 2014
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA