NCT01940315

Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B

A Phase 3, Double Blind, Placebo Controlled, Randomized, Multicenter Clinical Trial to Demonstrate the Safety, Lot Consistency and Clinical Benefit of Recombinant Botulinum Vaccine A/B (rBV A/B)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.

Detailed description

Currently, there are no licensed vaccines or pre-exposure prophylactic medical countermeasures available to provide protection against botulism. The rBV A/B is under development to provide protection of adults 18 to 55 years of age from fatal botulism caused by inhalational intoxication with botulinum neurotoxin complex (BoNT) serotype A, subtype A1 (BoNT/A1) and botulinum neurotoxin complex serotype B, subtype B1 (BoNT/B1). Volunteers will not be exposed to botulism. Protective antibody titers will be measured in serum after vaccination.

Conditions

• Botulism

Interventions

Type	Name	Description
BIOLOGICAL	rBV A/B	0.5 mL dose of rBV A/B (40 µg) given at Days 0, 28 ± 5 days, and 182 ± 9 days
BIOLOGICAL	Placebo (USP sterile saline for injection)	0.5 mL dose of Placebo will be given at Days 0, 28 ± 5 days, and 182 ± 9 days

Timeline

• Start date: 2017-10-01
• Primary completion: 2019-03-01
• Completion: 2019-09-01
• First posted: 2013-09-12
• Last updated: 2018-12-04

Regulatory

• FDA-regulated drug study