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DEVELOPMENT OF STABLE AND RAPIDLY ACTING ADJUVANTED VACCINES FOR BIODEFENSE

Award Number: U01AI082210
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: 09/24/2009
PERIOD OF PERFORMANCE END DATE: 08/31/2014

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DEVELOPMENT OF STABLE AND RAPIDLY ACTING ADJUVANTED VACCINES FOR BIODEFENSE - DESCRIPTION: (provided by the applicant) With the current emphasis on defined vaccines composed of protein subunits, there is a persistent need to improve the stability and performance of vaccines. Most vaccines are formulated in aqueous buffers and suspensions with aluminum salts adjuvants, vaccine immunogens degrade and lose potency (and efficacy). Elevated temperature increases the rate of protein degradation. As a result, liquid vaccines must be stored under refrigerated or frozen conditions. A well-controlled environmental cold chain must be maintained from the point of manufacture to the ultimate vaccinee. Temperature control will ultimately not be satisfactory in situations where vaccines are rarely used or not widely distributed especially where the vaccines are to be stockpiled for use for biodefense. The goal of this proposal is to develop processes and specific thermally stable formulations for two biodefense subunit vaccines adsorbed to aluminum adjuvants. This will be accomplished by using a drying technology and excipients that prevent the aggregation of aluminum adjuvant particles during freeze-drying and subsequent storage, while also preserving the structural and chemical integrity of the antigen. The vaccine subunits for study and development, a Ricin A chain vaccine (RTA V76M/Y80A, RiVax(tm)) and a hyperimmunogenic mutant (DNI, dominant negative inhibitor) of B. anthracis protective antigen (PA), are overall well characterized in physical and immunological properties. The first goal of this proposal is to develop and characterize the terminal step in manufacture of the vaccines, which would comprise lyophilization aluminum hydroxide-adsorbed subunit vaccines in the presence of stabilizing excipients, permitting retention of structure of the immunogens and functionality of the adjuvant. The second goal of this proposal is to develop vaccines that are more effective by employing well-characterized co-adjuvants that can be added to aluminum adjuvants subunits. This is expected to result in dried thermostable subunit vaccines that can be given in an accelerated regimen (fewer numbers of doses) and which result in more rapid onset of protective immunity.


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: 2013 ( Subtotal = $1,182,630 )
2013	2013	SOLIGENIX INC	1691 michigan ave, ste 436	miami	FL	33139		USA	Allergy and Infectious Diseases Research	000	5	8/7/2013	NON-COMPETING CONTINUATION	$1,182,630
														Subtotal = $1,182,630

Issue Date FY: 2012 ( Subtotal = $1,341,348 )
2012	2012	SOLIGENIX INC	1691 michigan ave, ste 436	miami	FL	33139		USA	Allergy and Infectious Diseases Research	000	4	8/15/2012	NON-COMPETING CONTINUATION	$1,341,348
														Subtotal = $1,341,348

Issue Date FY: 2011 ( Subtotal = $3,333,529 )
2011	2011	SOLIGENIX INC	1691 michigan ave, ste 436	miami	FL	33139		USA	Allergy and Infectious Diseases Research	000	3	8/18/2011	NON-COMPETING CONTINUATION	$3,333,529
														Subtotal = $3,333,529

Issue Date FY: 2010 ( Subtotal = $1,891,104 )
2010	2010	DOR BIOPHARAMA INC	1691 michigan ave, ste 436	miami	FL	33139		USA	Allergy and Infectious Diseases Research	001	2	8/23/2010	NON-COMPETING CONTINUATION	$1,891,104
2010	2009	SOLIGENIX INC	1691 michigan ave, ste 436	MIAMI	NJ	08540		USA	Allergy and Infectious Diseases Research	000	1	11/25/2009	NEW	$0
														Subtotal = $1,891,104

Issue Date FY: 2009 ( Subtotal = $1,305,761 )
2009	2009	DOR BIOPHARAMA INC	1691 michigan ave, ste 436	miami	FL	33139		USA	Allergy and Infectious Diseases Research	000	1	9/14/2009	NEW	$1,305,761
														Subtotal = $1,305,761

Grand Total All Awards = $9,054,372

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DEVELOPMENT OF STABLE AND RAPIDLY ACTING ADJUVANTED VACCINES FOR BIODEFENSE

Award Number: U01AI082210

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: 09/24/2009

PERIOD OF PERFORMANCE END DATE: 08/31/2014

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