NCT00764634

Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Dosing Schedule and Antibody Kinetics of Recombinant Botulinum Vaccine A/B, rBV A/B-40, in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.

Detailed description

The study includes 18 months (547 days) of follow-up after the first vaccination for all randomized volunteers who receive at least one vaccination. Analysis of cumulative data collected through Day 547 ± 14 days will be reported in the final clinical study report.

Conditions

• Botulism Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Placebo (USP sterile saline for injection)	0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
BIOLOGICAL	rBV A/B-40 vaccine	0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
BIOLOGICAL	Placebo (USP sterile saline for injection)	0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
BIOLOGICAL	rBV A/B-40 vaccine	0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-12-01
• First posted: 2008-10-02
• Last updated: 2011-12-02

Locations

6 sites across 1 country: United States