Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.

Starting soon · Phase 3

Conditions studied: Rabies (Healthy Volunteers)

In brief

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.

Key facts

Study ID

NCT07455318

Run by

Institute of Tropical Medicine, Belgium

People needed

561

Starts

2026-05-15

Expected to finish

2027-06-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 to ≤ 60 years of age at time of inclusion
• Willingness to provide written informed consent
• Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.

You may not qualify if…

• Known allergy to one of the components of the vaccine.
• Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).
• Note: See Section 6.3 for detailed guidance on immunomodulating therapies.
• Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.
• Ongoing pregnancy or active child wish at the time of booster vaccination (D0).
• Any other PrEP rabies vaccine schedule/vaccination than mentioned in the inclusion criteria.
• Previous rabies (s)PEP
• Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.

Where it is running

• 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

Full record on ClinicalTrials.gov

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