Phase 3 trial evaluating the immunogenicity and safety of a three-dose BioThrax® regimen for post-exposure prophylaxis in healthy adults

• Published in: Vaccine Vol. 32; no. 19; pp. 2217 - 2224
• Main Authors: Hopkins, Robert J., Howard, Cris, Hunter-Stitt, Ericka, Kaptur, Paulina E., Pleune, Brett, Muse, Derek, Sheldon, Eric, Davis, Matthew, Strout, Cynthia, Vert-Wong, Katya
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 17.04.2014; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; adults; Aged; Allergy and Immunology; Anthrax; Anthrax - prevention & control; Anthrax Vaccines - administration & dosage; Anthrax Vaccines - adverse effects; Anthrax Vaccines - immunology; Anthrax Vaccines - therapeutic use; anti-infective agents; Antibiotics; antibodies; Antibodies, Bacterial - blood; Antibodies, Neutralizing - blood; Antimicrobial agents; Applied microbiology; Bacteriology; Biological and medical sciences; BioThrax; Clinical trial; confidence interval; Diaries; disease control; Female; Fundamental and applied biological sciences. Psychology; Healthy Volunteers; Humans; immune response; Immunization, Secondary; Immunogenicity; injection site; Male; Microbiology; Middle Aged; Miscellaneous; Neutralization; pain; Post-Exposure Prophylaxis; Prophylaxis; rabbits; Safety; Toxins; Vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Young Adult; Clinical trial; Post-exposure prophylaxis; Vaccine; BioThrax; Immunogenicity; Anthrax; Bacillus anthracis; Bacillaceae; Infection; Prevention; Bacillales; Bacteriosis; Bacteria; BioThrax(®)

•BioThrax was well tolerated.•The primary success criterion at Day 63 was met.•Key secondary success criteria at Day 70 and Days 63–100 were met. This study was conducted to support licensure of a post-exposure prophylaxis indication for BioThrax® (anthrax vaccine adsorbed) concurrent with antimicro...