Rabies
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
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; - Immunocompromised due to medication such as prednisolone, TNF-alfa inhibitors, *biologicals* or immunodeficiency due to humoral or cellular cause.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the increase of antibody titer of participants. The endpoint is the percentage of participants with a fourfold antibody increase on either day 3, day 7 and day 14 after booster immunization as measured by the RFFIT. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of participants with a titer of > 0.5 IU/mL at day 0. | — |
Countries
Netherlands
Outcome results
None listed