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. "BAZOOKA_221"

Condition studied

Rabies infection/prophylaxis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster.

Endpoint detail

Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0)., Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 14 after the booster, geometric mean titers (GMTs) at all visits for all arms and the ratio with baseline GMTs per arm, Proportion of participants with swelling, pain, redness, headache, fever, or fatigue per arm., Proportion of participants with unsolicited (i.e., other) Adverse events per arm. Proportion of participants with unsolicited local reactions per arm., Proportion of participants with SAEs per arm throughout the study period after sPEP vaccination session. (EOT)