Detecting the antigen-specific B-cell-response to rabies vaccination.
- Conditions
- rabies10047438
- Registration Number
- NL-OMON54645
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
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.
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Detection of rabies-specific B-cells in peripheral blood of hyperimmunized<br /><br>volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quantification and phenotypical characterization of rabies-specific B-cells.</p><br>