Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

PHASE4CompletedINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

March 31, 2013

Study Completion Date

June 30, 2013

Conditions
Bacillus Anthracis (Anthrax)
Interventions
BIOLOGICAL

BioThrax®

BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups

BIOLOGICAL

BioThrax®

BioThrax® will be administered as: Arm A: 0.50mL SC injection on Days 0 and 14; Arm B: 0.50mL SC injection on Days 0 and 28; Arm C: 0.50mL SC injection on Days 0, 14 and 28; Arm D: 0.25 mL SC injection on Days 0, 14 and 28.

Trial Locations (4)

30322-1014

Emory Children's Center - Pediatric Infectious Diseases, Atlanta

45229-3026

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

98101-1466

Group Health Research Institute - Seattle, Seattle

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01641991 - Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule | Biotech Hunter | Biotech Hunter