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.
≥ 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.
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).
Parallel
Booster vaccination
Biological/VaccineTo 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.
Primary: boostability
To investigate whether the boostability of a (A) two-visit IM, (B) two-visit ID and (C) one-visit ID Pre-exposure Prophylaxis (PrEP) regimen is non-inferior to a theoretical 99% boostability when a single-dose IM simulated Post Exposure Prophylaxis (sPEP) is administered at least 5 years after the PrEP regimen. Primary Endpoint: Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) level, WHO standard) on Day 7 after the booster.
RFFIT levels ≥ 0.5 IU/mL Day 14
To estimate per arm the proportion of participant with adequate immune response on Day 14 after the booster. RFFIT levels ≥ 0.5 IU/mL is the WHO standard for adequate immune response.
FFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0).
To estimate per arm the proportion of participant with RFFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0). RFFIT levels ≥ 0.5 IU/mL is the WHO standard for adequate immune response.
RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster
To estimate per arm the proportion of participant with RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster. A titre ≥ 3.0 IU/ml is considered to be a proxy for good/robust protection.
RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster.
To estimate per arm the proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster. A titre ≥ 3.0 IU/ml is considered to be a proxy for good/robust protection.
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