rabies
Conditions
Interventions
Phase II: single intramuscular vaccination with Rabipur vaccine.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Phase I Hyperimmunized: - 18 years old or older. - Received at least 3 rabies vaccinations. - Able to provide informed consent. Control: - 18 years old or older. - Never received rabies vaccinations. - Able to provide informed consent. Phase II Previously immunized: - 18-35 years old - Received at least 2 rabies vaccinations. - Able to provide informed consent. Control: - 18-35 years old - Never received rabies vaccinations. - Able to provide informed consent.
Exclusion criteria
Exclusion criteria: - History of (pre)syncope associated with medical procedures involving needles - Received any vaccination other than rabies within three months prior to inclusion. - Administration of plasma or blood products within three months prior to inclusion - Bleeding disorders or use of anticoagulants - Any current infectious disease. - Immunocompromised (due to medication, medical condition, or other) Additional exclusion criteria for Phase II include: - 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 - Pregnancy or breastfeeding - Received any kind of vaccine in the month prior to inclusion - Plans to receive any (rabies) vaccination(s) during the study (from day 0 to day 28)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of rabies-specific B-cells in peripheral blood of hyperimmunized volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification and phenotypical characterization of rabies-specific B-cells. | — |
Countries
Netherlands
Outcome results
None listed