More than 600 healthy adults have now received intranasal administration of a range of doses of BPZE1 in two Phase 1 and four Phase 2 clinical studies without any vaccine-related serious adverse events (SAE) and a clean overall safety profile.
| Study | Nature of Study | Size if Treatment Group | Key Outcome(s) Measured |
|---|---|---|---|
| Ph. 1a | Dose Escalation | 48 (36 BPZE1) |
Completed Jan. 2012 |
| Ph. 1b | Dose Escalation | 54 (42 BPZE1) |
Completed Jun. 2017 |
| Ph. 2a | Dose Comparison | 50 (35 BPZE1) |
Completed May 2020 |
| Ph. 2b (“IB-200P”) | Adult Study (Attenuated Challenge: BPZE1 vs. Boostrix) | 300 (250 BPZE1) |
Completed Jun. 2020 |
| Ph. 2b (“CHAMPION-1”) | Human Virulent Challenge Study | 46 Challenged (26 BPZE1) |
Completed May 2024 |
| Ph. 2b (“SUPER”) | School Age Study (6 –17 years-age; aP primed population) | 366 (240 BPZE1) |
Completed Mar. 2025 |