Anthrax, though most commonly occurring in animals, can be extremely deadly to humans. Current vaccines can cause acute side effects and may provide only partial protection against some anthrax strains. Tests demonstrate that BlueWillow’s proprietary nanoemulsion (NE) adjuvant could deliver the next generation of anthrax vaccines.
Anthrax, caused by the spore-forming bacterium Bacilus anthracis, most commonly occurs in wild and domestic animals. Anthrax occurs in humans when they are exposed to infected animals, or when they are directly exposed to B. anthracis. For humans, the mortality of untreated cutaneous anthrax ranges up to 25% – and increases to nearly 100% in inhalational and intestinal cases.
The currently available vaccination schedule for anthrax consists of five intramuscular injections at months 0, 1, 6, 12 and 18, followed by annual booster injections thereafter. Evidence indicates that the current vaccine can cause acute side effects and may provide only partial protection against some strains of B. anthracis.
Scientists at the University of Michigan, working with the Battelle Memorial Institute, demonstrated that BlueWillow’s NE adjuvant could enable the next generation of anthrax vaccine. An intranasal NE-rPA vaccine was tested in mice and guinea pigs, in which it induced high titers of anti-rPA IgG after two administrations. In addition, the vaccine demonstrated durable long-term systemic immunity, mucosal immunity, and protection against challenge.
More recent studies conducted by Public Health England in conjunction with BlueWillow have demonstrated that two intranasal NE-rPA vaccinations in rabbits produces 90-100% protection following lethal anthrax challenge, even when very low doses of rPA antigen are used in the vaccine.
In 2012, BlueWillow Biologics partnered with Public Health England (PHE) to develop an intranasal anthrax vaccine for the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH. Under the terms of the NIAID contract, BlueWillow is supplying its NE adjuvant for use with PHE’s rPA antigen to enable the development of an intranasal vaccine that requires fewer doses than current treatments. The total value of the contract has the potential to reach up to $24 million if project milestones are met.