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Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.
Sponsor: Institute of Tropical Medicine, Belgium
Summary
A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.
Official title: A Multicentre, Open-label Trial in Healthy Volunteers to Assess the Boostability of Three Different Rabies Pre-exposure Prophylaxis Regimens When Administering a Single-dose, Intramuscular Vaccination as Simulated Post-exposure Prophylaxis at Least Five Years Following Priming.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
561
Start Date
2026-05-15
Completion Date
2027-06
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Booster vaccination
To investigate whether the boostability of a (A) two-visit IM, (B) two-visit ID and (C) one-visit ID pre-exposure vaccination regimen is non-inferior to a theoretical 99% boostability by administering a single-dose IM booster to simulate exposure to rabies at least 5 years after the pre-exposure regimens regimen.
Locations (6)
Clinical Trial Site Insitute of Tropical Medicine
Antwerp, Belgium
Cliniques Universitaires de Saint Luc
Brussels, Belgium
Centrum voor vaccinologie (CEVAC)
Ghent, Belgium
UZ Brussel
Jette, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Military Hospital Queen Astrid
Neder-Over-Heembeek, Belgium