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DEVELOPMENT OF PREVENTATIVE AND THERAPEUTIC HCV VACCINES

Award Number: R01AI060387
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: HEALTH SERVICES
PERIOD OF PERFORMANCE START DATE: 09/30/2003
PERIOD OF PERFORMANCE END DATE: 03/31/2007

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DEVELOPMENT OF PREVENTATIVE AND THERAPEUTIC HCV VACCINES - DESCRIPTION (provided by applicant): The overall objective of this proposal is to develop hepatitis C virus (HCV)-specific immunogens that may be useful as prophylactic and/or therapeutic vaccines for the prevention or treatment of chronic HCV infection. Two general nonexclusive approaches are proposed. In the first approach (Specific Aim 1) we propose to develop a prophylactic HCV vaccine designed to elicit neutralizing antibodies to the HCV E2 protein. For this purpose we have developed the woodchuck hepatitis core protein (WHcAg) as a particulate vaccine carrier platform. The WHcAg platform is capable of accommodating a variety of inserted B cell and CD4 + T cell epitopes and elicits extremely high levels of antibodies to the inserted B cell epitopes and primes insert-specific CD4 v T cells. Three categories of E2-specific neutralizing B cell epitopes will be inserted into the WHcAg vaccine platform: (a) highly conserved, non-HVR1 E2 epitopes that we have identified; (b) consensus sequences derived from the highly variable HVR1 region of E2, which will address the problem of genetic variability of HCV; and (c) conserved "framework motifs" present within the HVR1 region. The E2- WHcAg hybrid particles will be optimized for protein expression, assembly competence, yield in the E. coil expression system, antigenicity and immunogenicity. Because strong T cell responses (both CD4 vand CD8 v) against HCV antigens and especially the nonstructural 3 (NS3) protein have been linked to viral clearance in acute and chronic HCV infection, our second approach will be aimed at developing a NS3/4A-specific DNA vaccine candidate (Specific Aim 2). The NS3 protein is highly conserved and an advantage of a DNA vaccine is the ability to elicit CD4 v Th cells and CD8 v CTL as well as antibody. We have found that a NS3/4A gene elicits significantly more efficient immune responses than the widely used NS3 gene. It is anticipated that a NS3/4A DNA vaccine may be used for prophylactic or therapeutic applications either alone or in combination with E2-WHcAg hybrid particles.


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 = $415,608 )
2006	2006	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	4	2/10/2006	NON-COMPETING CONTINUATION	$415,608
														Subtotal = $415,608

Issue Date FY: 2005 ( Subtotal = $415,994 )
2005	2005	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Microbiology and Infectious Diseases Research	000	3	3/14/2005	NON-COMPETING CONTINUATION	$415,994
														Subtotal = $415,994

Issue Date FY: 2004 ( Subtotal = $406,659 )
2004	2004	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Microbiology and Infectious Diseases Research	000	2	3/8/2004	NON-COMPETING CONTINUATION	$406,659
														Subtotal = $406,659

Issue Date FY: 2003 ( Subtotal = $222,216 )
2003	2003	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Microbiology and Infectious Diseases Research	000	1	9/27/2003	NEW	$222,216
														Subtotal = $222,216

Grand Total All Awards = $1,460,477

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DEVELOPMENT OF PREVENTATIVE AND THERAPEUTIC HCV VACCINES

Award Number: R01AI060387

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: HEALTH SERVICES

PERIOD OF PERFORMANCE START DATE: 09/30/2003

PERIOD OF PERFORMANCE END DATE: 03/31/2007

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