NCT01701999View on ClinicalTrials.gov

Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

October 31, 2015

Conditions
Botulism
Interventions
BIOLOGICAL

rBV A/B

rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.

Trial Locations (2)

43162

Battelle Biomedical Research Center, West Jefferson

94804

California Department of Public Health, Richmond

All Listed Sponsors
lead

California Department of Public Health

OTHER

NCT01701999 - Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid | Biotech Hunter | Biotech Hunter