NCT03676634

Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®

Tolerability and Immunogenicity of a Single 40-µg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG® in Volunteers With Existing Botulinum Immunity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: California Department of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Botulism

Interventions

Type	Name	Description
BIOLOGICAL	rBV A/B	Recombinant Botulinum Vaccine A/B, rBV A/B

Timeline

• Start date: 2019-03-07
• Primary completion: 2020-04-25
• Completion: 2020-07-03
• First posted: 2018-09-19
• Last updated: 2021-10-19
• Results posted: 2021-10-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study