*Dutch Marines study on Rabies antibody response after Boostering an intradermal pre-exposure scheme (MaRaBoo study)*
- Conditions
- Rabies10047438
- Registration Number
- NL-OMON45312
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Healthy military volunteers that received a completed intradermal immunization last year or 2 years ago.
- 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;
- Immune compromised 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 percentage of participants with a titer of * 0.5 IU/ml at day 7<br /><br>The percentage of participants with a titer of * 0.5 IU/ml at day 14</p><br>
- Secondary Outcome Measures
Name Time Method <p>The percentage of participants with a titer of * 0.5 IU/ml at day 0<br /><br>The percentage of participants with a titer of * 3.0 IU/ml at day 7<br /><br>The percentage of participants with a titer of * 3.0 IU/ml at day 14</p><br>