rabies
Conditions
Interventions
Study group A: 1-site intradermal injection of 0,1 mL rabies vaccine
per site at d0 using N&S.
Study group B: 2-site intradermal injection of 0,1 mL rabies vaccine per site
at d0 using N&S.
Study gr
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects are required to fulfill all of the following criteria: • Age >= 18 years • Good health according to the investigator • Willingness and ability to adhere to the study regimen • Able to give informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for this study are: • 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 • 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 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 • Temporary exclusion criterion for vaccination: Body temperature >= 38.5ºC 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 |
|---|---|
| - Memory response to standard booster vaccination (IM d0 d3) at 1 year post primary vaccination (defined as 100% seroprotection [RVNA >0,5 IU/mL as measured by FAVN] for all subjects in the dose level within or at 7 days post-booster). In case all subjects within a dose group are still protected at the booster baseline of day 365, the primary endpoint will be a 4-fold increase in RVNA GMT for that group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7.1.2 Secondary endpoints related with immunogenicity: - Rabies seroprotection rate in each group at baseline, d14-16 and d28-35 after primary vaccination; defined as seroconversion. - Geometric mean titres of rabies virus neutralizing antibody (RVNA GMT by FAVN) in each group at D14, D28-35, D365 and D368, D372. 7.1.3 Secondary endpoints of safety: - Loss of vaccine at the injection site. - Size of intradermal wheal after vaccination - Discomfort caused by vaccination technique; - Number of vaccination technique failures; - Frequency and severity of local and systemic adverse events. | — |
Countries
Netherlands
Outcome results
None listed