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*Dutch Marines study on Rabies antibody response after Boostering an intradermal pre-exposure scheme (MaRaBoo study)*

Completed
Conditions
Rabies
10047438
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
Inclusion Criteria

Healthy military volunteers that received a completed intradermal immunization last year or 2 years ago.

Exclusion Criteria

- 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
NameTimeMethod
<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
NameTimeMethod
<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>
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