Biothrax, Anthrax Vaccine Adsorbed, is made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis.
Biothrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age whose occupation or other activities place them at high risk of exposure.
BioThrax is currently licensed for post-exposure prophylaxis and pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure.
Biothrax is administered either as an intramuscular or subcutaneous injection only.
Clinical Trial NCT03877926: A Phase 3, multicenter, randomized, double-blind, parallel-group trial designed to evaluate the lot consistency (using three consecutively manufactured lots), immunogenicity, and safety of AV7909 administered in healthy adults for an indication of postexposure prophylaxis (PEP) of anthrax
AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant.
AVA drug substance is identical in composition and manufacturing process to commercial BioThrax.
CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.