Emergent BioSolutions said on Tuesday it will begin a Phase 3 trial of a new anthrax vaccine it is developing.
The Phase 3 trial will evaluate the lot consistency, immunogenicity, and safety of the vaccine, called AV7909. AV7909 is designed to elicit a faster immune response than other anthrax vaccines that are currently available.
Specifically, AV7909 is an Anthrax Vaccine Adsorbed (AVA) with CPG 7909 adjuvant. It follows a two-dose schedule administered intramuscularly in healthy adults. The vaccine is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis, or anthrax, exposure.
“Emergent is pleased with the advancement of the AV7909 development program,” Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions, said. “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.”
Adding the compound CPG 7909 adjuvant to AVA was shown in Phase 1 and Phase 2 studies to safely accelerate and enhance the immune response, the company said. The Phase 3 study will involve 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months.
Emergent BioSolutions, based in Gaithersburg, Md., is a global life sciences company that provides specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats.
Emergent currently manufactures BioThrax, the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax disease. Over 14 million doses of BioThrax have been administered to more than 3 million individuals, the company said last year.