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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"

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524765-24-00
Enrollment
561
Registered
2026-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies infection/prophylaxis

Brief summary

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.

Detailed description

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)

Interventions

Sponsors

Institute Of Tropical Medicine
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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)

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026