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Protective Antigen Complex

Improved vaccine for Bacillus anthracis has elevated resistance to premature degradation through increased thermal and structural stability.

Bacillus anthracis, more commonly known as Anthrax, is a bacterial toxin and is regarded to be a potential threat for biowarfare or bioterrorism. Exposure to aerosolized B. anthracis spores is toxic and lethal to humans and mammals, and can have devastating consequences if ever used as an agent for bioterrorism.

Anthrax has been used as a weapon around the world for nearly a century and is classified by the CDC as a Tier 1 agent. In 2001, powdered Anthrax spores were placed into letters and mailed through the U.S. Postal System. A total of 22 people were infected with Anthrax and five casualties. The spores can easily be found in nature or produced in a lab, and can survive for long periods in harsh environments. The microscopic spores can be easily placed in powders, sprays, food, and water, and are often unable to be seen, smelled, or tasted. The infection can occur in four forms: skin, inhalation, intestinal, and injection. Symptoms are different for each infection type, and range from skin lesions, abscess formation, fever, chest pain, vomiting, and abdominal pain.

LIMITATIONS OF THE CURRENT VACCINE:
The only licensed human vaccine in the U.S. is Anthrax Vaccine Adsorbed (AVA), commercially known as BioThrax. FDA vaccination requirements for pre-exposure to Anthrax involve a primary series of three doses and require a booster series at yearly intervals following the primary series. The vaccine must be stored and refrigerated at 2 ⁰C – 8 ⁰C (36 ⁰F – 46 ⁰F) to retain efficacy.

Potency is reduced each time the vaccine is exposed to improper conditions. Without specialized transport with cold chain storage to keep the vaccine between 2 ⁰C – 8 ⁰C, wide distribution is a challenge. Any period of temperature excursion will result in the physical or chemical degradation of the protein structures that are critical for inducing protective immunity. Improper storage of the vaccine at the necessary conditions will result in a complete loss of efficacy and be rendered useless.

Antigen

NEW VACCINE COMPLEX UNDETERRED BY PREVIOUS RESTRICTIONS:
Protective antigen is the protein responsible for transporting Lethal Factor (LF) and Edema Factor (EF) into the host cell. Reseachers developed an advanced Protective Antigen Complex to elicit an immunogenic response in a subject and induce protective immunity. The complex has elevated resistance to PA folding and pore formation, preventing LF and EF from comprising immunity in the cell. The invented complex also raises the thermal stabilty by at least 20 ⁰C compared to the prior serum. By acheiving storage of the vaccine at 25 ⁰C , this eliminates the necessity for specialized transport containers with temperature control. This will allow for the wide distribution of the vaccine, making it easily accessible in underdevloped areas with scarce medical resources.

Additional Details

Owner

Wichita State University

Intellectual Property Protection

Pending Patent



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