Rabies antibody respons after booster vaccination, > 10 years after pre-exposure scheme (RAR-boost study)
- Conditions
- Rabies10047438
- Registration Number
- NL-OMON47356
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
- Healthy human volunteers in the AMC travel clinic with intradermal immunization or not completed scheme or divergent timetable intramuscular immunization more than 10 years ago.
- Healthy military volunteers from the Marine Corps that received a completed intramuscular immunization more than 10 years ago and eligible for a booster immunization.
- Age < 18 years;
- No previous booster immunization;
- No previous post-exposition treatment with HRIG;
- Potential deployment to rabies endemic area within study period ;
- Presence of a serious medical history with a potential effect on the immune system such
as diabetes mellitus, HIV, functional or hyposplenia/asplenia;
- Allergies to one of the components of the rabies vaccine such as chicken egg protein,
polygeline, hypersensitivity to neomycin, chlortetracycline, amphotericin B and other
antibiotics of the same class;
- Use of mefloquine or chloroquine during the study period ;
- Pregnancy ;
- Breastfeeding;
- Immunocompromised due to medication such as prednisolone, TNF-alfa inhibitors,
*biologicals* or immunodeficiency due to humoral or cellular cause.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the increase of antibody titer of participants.<br /><br>The endpoint is the percentage of participants with a fourfold antibody<br /><br>increase on either day 3, day 7 and day 14 after booster immunization as<br /><br>measured by the RFFIT.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The percentage of participants with a titer of > 0.5 IU/mL at day 0.</p><br>