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VITRIFICATION-STABILIZED MULTIVALENT BOTULINUM VACCINES

Award Number: UC1AI062531
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2004
PERIOD OF PERFORMANCE END DATE: 08/31/2009

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VITRIFICATION-STABILIZED MULTIVALENT BOTULINUM VACCINES - DESCRIPTION (provided by applicant): The development of a safe, efficacious vaccine to protect against the seven known naturally occurring serotypes of botulinum neurotoxins would effectively eliminate them as weapons of mass destruction. It is essential that any vaccine include all antigens to protect against all seven serotypes. This is a significant challenge that requires the naturally unstable properties of proteins to be overcome. The aim of this project is to develop ultrastable heptavalent botulinum vaccines. DynPort Vaccine Company, LLC proposes to achieve this by formulating botulinum vaccine antigens in water soluble sugar glasses that entrap proteins, minimizing protein interactions with themselves and their environment, as well as shielding them from the effects of thermal and chemical stresses. Individually formulated antigens will be combined and prepared as monodisperse suspensions in a Perfluorcarbon. Approved by the FDA for use in humans, these inert chemicals enhance stability and provide a suitable delivery vehicle for human immunization, because of its low viscosity, high lubricity and simple respiratory elimination from the body. Their inclusion ensures that the delivery vehicle and vaccine are in the same vial, further enhancing the utility and management of the vaccine. The resulting ultrastable formulations will effectively eliminate the cold chain of vaccine management, constraining vaccine replacement to use rather than stability. We believe that we are uniquely placed to meet the aim of this program. We are funded through the DoD and NIAID to develop multivalent recombinant botulinum vaccine formulations, and the scientific and technical knowledge at DVC will be leveraged to facilitate vaccine formulation design intended for potential future CGMP production. DVC is partnering with Cambridge Biostability Ltd, which has developed and demonstrated this formulation technology for several vaccines. Finally, DVC is also partnering with Battelle Memorial Institute, which has a proven track record in the performance of assays to assess the potency of the botulinum neurotoxin related vaccines and therapeutics.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2009 ( Subtotal = $0 )
2009	2004	DYNPORT VACCINE COMPANY LLC	64 THOMAS JEFFERSON DRIVE	FREDERICK	MD	21702	FREDERICK	USA	Microbiology and Infectious Diseases Research	000	1	10/9/2008	NEW	$0
2009	2004	DYNPORT VACCINE COMPANY LLC	64 THOMAS JEFFERSON DRIVE	FREDERICK	MD	21702	FREDERICK	USA	Microbiology and Infectious Diseases Research	001	1	3/10/2009	NEW	$0
														Subtotal = $0

Issue Date FY: 2004 ( Subtotal = $5,388,306 )
2004	2004	DYNPORT VACCINE COMPANY LLC	64 THOMAS JEFFERSON DRIVE	FREDERICK	MD	21702	FREDERICK	USA	Microbiology and Infectious Diseases Research	000	1	8/30/2004	NEW	$5,388,306
														Subtotal = $5,388,306

Grand Total All Awards = $5,388,306

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VITRIFICATION-STABILIZED MULTIVALENT BOTULINUM VACCINES

Award Number: UC1AI062531

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2004

PERIOD OF PERFORMANCE END DATE: 08/31/2009

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