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MULTIEPITOPE CIRCUMSPOROZOITE P.FALCIPARUM MALARIA SUBUNIT VACCINE DISPLAYED ON V

Award Number: R01AI082740
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2009
PERIOD OF PERFORMANCE END DATE: 08/31/2013

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MULTIEPITOPE CIRCUMSPOROZOITE P.FALCIPARUM MALARIA SUBUNIT VACCINE DISPLAYED ON V - Summary Statement Given the very high burden malaria imposes on many developing countries, the overall objective of this proposal is to develop a P. falciparum malaria-specific immunogen that may be useful as an affordable and effective vaccine to prevent malaria. The current most effective malaria vaccine candidate (RTS,S/AS02A) is based on the use of a particulate carrier platform (the HBsAg) fused to malaria circumsporozoite (CS)-specific T and B cell epitopes. Current limitations of the RTS,S vaccine have been a requirement for reactogenic adjuvants and transient protection. A further potential complication is that the carrier is derived from a human pathogen, the hepatitis B virus (HBV). To circumvent these problems a non-human pathogen-derived carrier platform has been developed, specifically the core protein from the woodchuck hepadnavirus (WHcAg). Modified WHcAg particles will be used as the vaccine platform for several reasons: CS-WHcAg hybrid particles elicit extremely high levels of anti-CS antibodies; the immune tolerance to HBcAg and HBsAg in HBV chronic carriers (400 million worldwide) can be circumvented by the use of the WHcAg platform; and because CS- WHcAg hybrid particles can be made in bacteria, production of a vaccine will be relatively inexpensive. A preliminary CS-WHcAg hybrid particle has been developed that contains two neutralizing CS repeat epitopes inserted into the loop region (the insertion site that raises the highest titer anti-insert antibodies) and two "universal" malaria-specific T cell domains fused to the C-terminus. This CS-WHcAg hybrid particle is very immunogenic in mice and is capable of eliciting neutralizing anti-CS repeat antibodies that prevent P. falciparum/P. berghei hybrid sporozoite liver infection in vivo, therefore it is an ideal basis from which to develop a vaccine for human use. The strategy for developing an optimal malaria vaccine is divided into four aims: 1) incorporation of additional CS-derived B cell and T cell neutralizing epitopes; 2) testing the protective efficacy of the vaccine candidates in a hybrid P. falciparum/P. berghei sporozoite model and developing the model to encompass additional P. falciparum epitopes; 3) test recombinant and chemically linked "molecular adjuvants" for their ability to improve protective efficacy of the vaccine particles; and 4) determine optimal formulation, route and dosing of the chosen vaccine candidates. The combination of these two powerful technologies, the WHcAg-carrier platform and the P. falciparum/P. berghei hybrid sporozoite challenge model, will enable the production of a variety of CS-WHcAg hybrid particle immunogens that can be tested for protective efficacy in an in vivo infectious model system specific for P. falciparum malaria.


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: 2012 ( Subtotal = $639,675 )
2012	2012	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	4	8/9/2012	NON-COMPETING CONTINUATION	$639,675
														Subtotal = $639,675

Issue Date FY: 2011 ( Subtotal = $597,424 )
2011	2011	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	3	8/10/2011	NON-COMPETING CONTINUATION	$597,424
														Subtotal = $597,424

Issue Date FY: 2010 ( Subtotal = $599,338 )
2010	2010	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	001	2	8/19/2010	NON-COMPETING CONTINUATION	$599,338
2010	2009	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	1	11/19/2009	NEW	$0
														Subtotal = $599,338

Issue Date FY: 2009 ( Subtotal = $594,705 )
2009	2009	VACCINE RESEARCH INSTITUTE OF SAN DIEGO	3030 SCIENCE PARK ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	1	8/26/2009	NEW	$594,705
														Subtotal = $594,705

Grand Total All Awards = $2,431,142

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MULTIEPITOPE CIRCUMSPOROZOITE P.FALCIPARUM MALARIA SUBUNIT VACCINE DISPLAYED ON V

Award Number: R01AI082740

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2009

PERIOD OF PERFORMANCE END DATE: 08/31/2013

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