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 administered either as an intramuscular or subcutaneous injection only.
July 30, 2019: Emergent BioSolutions Inc. announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised its first contract option valued at $261 million to procure doses of AV7909 (BioThrax adsorbed with adjuvant) for delivery into the Strategic National Stockpile (SNS) over 12 months.
Clinical Trial NCT01641991: Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax AVA Schedule
- This is a Phase IV, randomized, open-label immunogenicity and safety study to evaluate four dosing regimens of BioThrax for Post-Exposure Prophylaxis (PEP) for anthrax.
- BioThrax will be administered as a subcutaneous (SC) injection for the primary series and will be administered as an intramuscular (IM) injection for the boost.
- The four dosing regimens are: 0.50mL BioThrax® on Days 0, 14, and 6 month boost; 0.50mL BioThrax® on Days 0, 28 and 6 month boost; 0.50mL BioThrax® on Days 0, 14, 28 and 6 month boost and 0.25mL BioThrax® on Days 0, 14, and 28, 6 month boost with 0.50ml IM
- Approximately 300 subjects will be randomized 1:1:1:1 to one of the four study arms. Enrollment will be stratified by gender, with approximately equal numbers of males and females (18 through 65 years) enrolled in each dosing regimen.
- The primary objective is to evaluate the immunogenicity of the four dosing regimens of BioThrax using the Toxin Neutralization Assay (TNA).
- The secondary objective is to evaluate the safety of the four dosing regimens of BioThrax.