Over 500 healthy adults and children have now received intranasal administration of a range of doses of BPZE1 in two Phase 1 and four Phase 2 clinical studies without vaccine-related serious adverse events (SAE) and with a clean overall safety profile.
| Study | Nature of Study | Size of Treatment Group | Key Outcome(s) Measured | Status |
|---|---|---|---|---|
| Ph. 1a | Dose Escalation | 48 (36 BPZE1) |
Completed Jan. 2012 | Colonization Rate / Immunological Response |
| Ph. 1b | Dose Escalation | 54 (42 BPZE1) |
Completed Jun. 2017 | Examined 3 Consecutive Dose Groups (10*7, 10*8, 10*9 CFU) |
| Ph. 2a | Dose Comparison | 50 (35 BPZE1) |
Completed Follow Up May 2020 | Comparing Two Dosages (10*7 & 10*9 CFU) |
| Ph. 2b (“IB-200P”) | Adult Study (Attenuated Challenge: BPZE1 vs. Boostrix) | 300 (250 BPZE1) |
Completed Jun. 2020 | Outperformed Boostrix by 85% in Prevention of Colonization |
| Ph. 2b (“CHAMPION-1”) | Human Virulent Challenge Study | 46 Challenged (26 BPZE1) |
Primary Data Aug. 2023 Final report completed in May 2024 | Primary Endpoint: B. Pertussis Colonization at Days 9, 11, and 14 |
| Ph. 2b (“SUPER”) | School Age Study (6 –17 years-age; aP primed population) | 366 (240 BPZE1) |
Interim analysis completed in May 2024 Final report in Q1 2025 | Primary Endpoint: Mucosal S IgA against WCE and 7-day reactogenicity Key Secondary Endpoint: non-interference for BPZE1 alone vs. Boostrix vs. BPZE1 + Boostrix |