Single-dose anthrax vaccine enters clinical trial with HHS support

FOR IMMEDIATE RELEASE Monday, August 1, 2016	Contact: HHS Press Office (202) 690-6343 media@hhs.gov

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.

Altimmune previously demonstrated that NasoShield provides protection in a single dose from exposure to anthrax in preclinical studies. In the planned clinical studies, the vaccine candidate will be tested for safety and its effectiveness in eliciting an immune response in humans, although participants will not be exposed to anthrax. If development is successful and the product earns FDA licensure, the product would be administered as a nasal spray to protect against infections caused by inhalation anthrax.

In addition to advanced development of NasoShield, BARDA has supported improvement of the currently licensed vaccine, BioThrax, so that fewer doses may be needed to protect against anthrax, as well as other novel vaccines that may require fewer doses, antibiotics and antitoxins. Funding and expertise from BARDA led BioThrax to become the first vaccine to earn FDA approval for post-exposure protection. FDA also has approved use of four anthrax-related antibiotics and two anthrax antitoxins developed with BARDA support.

BARDA takes a comprehensive and integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency caused by chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases.

The CIADMs were established in the wake of the 2009 H1N1 influenza pandemic and are a core component of ASPR/BARDA’s National Medical Countermeasures Response Infrastructure. This infrastructure provides core services for private partners to speed development, manufacturing and availability of drugs, vaccines and medical devices including diagnostic tests. Other core services provided through the response infrastructure include a nonclinical studies network, a clinical studies network, and a fill-finish manufacturing network that fills and finishes vials of drugs or vaccines.

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

For more information on national public health and medical preparedness, visit www.phe.gov. To learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.

# # #

Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.