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ADVANCED ANTHRAX VACCINE MADE WITH ISS DNA FORMULATIONS

Award Number: U01AI056559
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: HEALTH SERVICES
PERIOD OF PERFORMANCE START DATE: 07/15/2003
PERIOD OF PERFORMANCE END DATE: 12/31/2006

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ADVANCED ANTHRAX VACCINE MADE WITH ISS DNA FORMULATIONS - DESCRIPTION (provided by applicant): We propose to use ISS to develop an improved anthrax vaccine that will be safe and will provide immunity after one or two immunizations. This vaccine will be compromised of recombinant anthrax protective antigen (rPA) delivered with an immunostimulatory (ISS) oligonucleotide adjuvant enhanced by a novel coacervate formulation. We will compare the ISS sequence currently in clinical trials, 1018, with our more active ISS sequence, C274 to identify the most potent vaccine formulation. The use of ISS in the novel coacervate carrier should provide dramatic enhancement of both the speed and magnitude of the antibody response developed against rPA compared to current second generation approaches using rPA adsorbed to alum or compared to the currently licensed vaccine, AVA. The specific aims for this project are: 1. To test the immunogenicity of recombinant anthrax protective antigen (rPA) with and without combination with ISS coacervate formulations in mice, rabbits, and rhesus macaques; sera will be evaluated by PA-specific ELISAs and for the capacity to neutralize the anthrax toxins using in vitro cell culture assays. 2. To establish the ability of 1-2 doses of the optimized ISS coacervate/rPA vaccine to protect experimental animals against anthrax in vivo following challenge with Bacillus anthracis spores. A. Protection of mice against challenge with B. anthracis spores administered by the intranasal route. B. Protection of rabbits against inhalation anthrax following aerosol challenge with B. anthracis spores. C. Protection of rhesus macaques against inhalation anthrax following challenge with B. anthracis spores. 3. To perform toxicological evaluation and to initiate GMP production of the ISS coacervate/rPA vaccine, assuming positive results in Specific Aims 1-3. Because of the high cost of the later Specific Aims (Aims 3C and 4), activities for each Specific Aim will be performed sequentially, and feasibility will be established before the project moves onto the next Aim. Assuming success in the individual Specific Aims, this proposal is intended to produce an IND-ready new anthrax vaccine that could rapidly move into clinical testing.


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: 2006 ( Subtotal = $2,098,735 )
2006	2006	DYNAVAX TECHNOLOGIES CORPORATION	717 POTTER STREET SUITE 100	BERKELEY	CA	94710	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	4	1/25/2006	NON-COMPETING CONTINUATION	$2,098,735
														Subtotal = $2,098,735

Issue Date FY: 2004 ( Subtotal = $456,128 )
2004	2004	DYNAVAX TECHNOLOGIES CORPORATION	717 POTTER STREET SUITE 100	BERKELEY	CA	94710	ALAMEDA	USA	Microbiology and Infectious Diseases Research	000	2	1/23/2004	NON-COMPETING CONTINUATION	$456,128
														Subtotal = $456,128

Issue Date FY: 2003 ( Subtotal = $234,644 )
2003	2003	DYNAVAX TECHNOLOGIES CORPORATION	717 POTTER STREET SUITE 100	BERKELEY	CA	94710	ALAMEDA	USA	Microbiology and Infectious Diseases Research	000	1	7/11/2003	NEW	$234,644
														Subtotal = $234,644

Grand Total All Awards = $2,789,507

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ADVANCED ANTHRAX VACCINE MADE WITH ISS DNA FORMULATIONS

Award Number: U01AI056559

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: HEALTH SERVICES

PERIOD OF PERFORMANCE START DATE: 07/15/2003

PERIOD OF PERFORMANCE END DATE: 12/31/2006

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