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Single-Dose Anthrax Vaccine Enters Clinical Trial with HHS Support

An anthrax vaccine that could be administered in a single dose is advancing to its first clinical trial with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The only anthrax vaccine approved by the U.S. Food and Drug Administration (FDA) requires three doses.

Under a two-year, approximately $14 million contract between ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Altimmune, Inc. of Gaithersburg, Maryland, the company will begin the first clinical trial of its anthrax vaccine NasoShield. If the vaccine performs well during clinical studies, the contract could be extended an additional three years and up to a total of approximately $120 million to support additional clinical and nonclinical studies and scale-up manufacturing.

“Fifteen years ago we experienced a U.S. public health crisis with anthrax-laden letters sent through the mail, and anthrax remains a bioterrorist threat today,” said Dr. Richard Hatchett, BARDA’s acting director. “The sooner people are protected by vaccine after being exposed to anthrax, the more lives we can save. A single dose vaccine is ideal to provide fast protection and peace of mind in the critical days after an incident.”

The NasoShield vaccine is unique in that it is administered as an intranasal spray instead of an injection. The vaccine uses a genetically modified Adenovirus 5 as the delivery system. With this system, a non-infectious virus is modified to include genetic material from the anthrax bacteria genome needed to produce an immune response against anthrax.
In May 2016, ASPR issued a task order to one of its Centers for Innovation in Advanced Development and Manufacturing (CIADM) to produce the material that will be used for the clinical trial. It marked the first time a CIADM was used to support the development of a candidate vaccine or drug.

Read full article here: http://www.phe.gov/Preparedness/news/Pages/single-anthrax-160801.aspx