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Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis
EU CTIS ID: 2023-510480-35-00
What this study is testing
To demonstrate the presence of a rapid and adequate anamnestic antibody response against rabies virus vaccine five years after primary vaccination with a single intramuscular dose (1.0 mL) of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 8 after a simulated standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group who received primary vaccination with two-visit, single-dose PrEP.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 40 years
- Good health according to investigator
- Willingness and ability to adhere to the study regimen
- Able to provide informed consent
- Naïve to rabies exposure or vaccination
- Willing to comply to a follow-up of 5 years
You likely can't join if
- History of previous rabies vaccination
- History of any neurological disorder including epilepsy
- Pregnancy or breastfeeding during study visits in which the participant is vaccinated
- Any current infectious disease other than seasonal cold
- Bleeding disorders or use of anticoagulants
- Suspected previous vaccination against rabies
See the full eligibility criteria
- Age between 18 and 40 years
- Good health according to investigator
- Willingness and ability to adhere to the study regimen
- Able to provide informed consent
- Naïve to rabies exposure or vaccination
- Willing to comply to a follow-up of 5 years
- Unlikely to require rabies PrEP in next 5 years
- History of previous rabies vaccination
- History of any neurological disorder including epilepsy
- Pregnancy or breastfeeding during study visits in which the participant is vaccinated
- Any current infectious disease other than seasonal cold
- Bleeding disorders or use of anticoagulants
- Suspected previous vaccination against rabies
- 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
- History of (pre)syncope associated with medical procedures involving n
- Immunocompromized state due to illness or medication
- Administration of plasma or blood products three months prior to inclusion
- (hydroxy)chloroquine or mefloquine use
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.