Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®

Summary

This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.

Timeline

Start

2024-07-09

Primary completion

2025-06-02

Completion

2025-06-02

Drugs

Indications