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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Tropical Medicine, Belgium

About this trial

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.

Eligibility criteria

Qualifiers

≥ 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.

Disqualifiers

Known allergy to one of the components of the vaccine.

Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).

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).

Trial design

Treatments tested in this trial

  • Booster vaccination

Treatment groups

561 Participants
are divided into 3 treatment groups