Therapeutic Anthrax Vaccine Candidate Launches Phase 3 Study
A Phase 3 clinical trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 anthrax vaccine candidate launched on April 23, 2019.
The AV7909 vaccine is being developed by Emergent BioSolutions Inc. for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.
AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine.
Abbey Jenkins, senior vice president at Emergent said in a press release, “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”
AV7909 is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909.
The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.
This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months.
The advanced development and delivery of AV7909 is funded by the Biomedical Advanced Research and Development Authority, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats.
Additional information about the company may be found here.