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PRODUCTION OF AN NP-ISS CONJUGATE VACCINE TO COMBAT PANDEMIC INFLUENZA.

Award Number: U01AI074578
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: 08/15/2007
PERIOD OF PERFORMANCE END DATE: 07/31/2009

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PRODUCTION OF AN NP-ISS CONJUGATE VACCINE TO COMBAT PANDEMIC INFLUENZA. - DESCRIPTION (provided by applicant): The goal of this proposal is to continue the product development of a novel vaccine approach that incorporates nucleoprotein (NP) as a conserved internal component of influenza virus linked to an immunostimulatory oligonucleotide to induce protective immunity against divergent and potentially pandemic influenza strains. Specifically, the plan is to complete process development and scale up for GMP production of recombinant NP in an E. coli system. Process development, scale-up and GMP production of the NP-ISS conjugate for the vaccine will then be performed, as well as IND enabling toxicology and stability studies. In addition, characterization of the immunogenicity and protective immunity provided by the NP-ISS vaccine alone and NP-ISS combined with standard trivalent inactivated vaccine will be performed in animal models. The Specific Aims of the proposal are: 1. Produce GMP-grade NP-ISS conjugate * GMP manufacture of recombinant nucleoprotein in the E. coli production system * Process development and scale-up of NP-ISS conjugate formulation * GMP manufacture of NP-ISS formulation 2. Perform IND enabling toxicology on NP-ISS vaccine q TIV 3. Perform further characterization of the NP-ISS vaccine. * Assess protection provided by E. coli derived NP-ISS in the mouse challenge model against drift (H1), shift (H3) and avian (H5) influenza strains. * Assess protection following immunization in the ferret influenza challenge model with drift (H1),shift (H3) and avian (H5) influenza strains. * Optimize the combination of NP-ISS and TIV in primates to allow HA dose sparing while inducing NP-specific cell mediated immunity. * Evaluate immunogenicity of the NP-ISS vaccine combined with trivalent inactivated vaccine in elderly mice.


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: 2008 ( Subtotal = $1,616,687 )
2008	2008	DYNAVAX TECHNOLOGIES CORPORATION	717 POTTER STREET SUITE 100	BERKELEY	CA	94710	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	2	8/6/2008	NON-COMPETING CONTINUATION	$1,616,687
														Subtotal = $1,616,687

Issue Date FY: 2007 ( Subtotal = $1,600,000 )
2007	2007	DYNAVAX TECHNOLOGIES CORPORATION	717 POTTER STREET SUITE 100	BERKELEY	CA	94710	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	8/6/2007	NEW	$1,600,000
														Subtotal = $1,600,000

Grand Total All Awards = $3,216,687

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PRODUCTION OF AN NP-ISS CONJUGATE VACCINE TO COMBAT PANDEMIC INFLUENZA.

Award Number: U01AI074578

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: 08/15/2007

PERIOD OF PERFORMANCE END DATE: 07/31/2009

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