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

Botulism Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01940315
Study type Interventional
Source DynPort Vaccine Company LLC, A GDIT Company
Contact
Status Withdrawn
Phase Phase 3
Start date October 2017
Completion date September 2019
View Details
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