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An Orally Delivered Booster Vaccine Candidate for Hepatitis B

Award Number: R44AI068239
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: 11/01/2005
PERIOD OF PERFORMANCE END DATE: 04/30/2015

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An Orally Delivered Booster Vaccine Candidate for Hepatitis B - DESCRIPTION (provided by applicant): There are 350 million people chronically infected with hepatitis B virus who have a high risk for cirrhosis of the liver and liver cancer resulting in approximately a million deaths annually. This is an alarming rate as there has been a safe and efficacious vaccine on the market for more than twenty years. High costs of production, distribution and administration have limited use of this vaccine in developing nations. The inconvenience of clinic visits and fear of injections restrict compliance worldwide. It is an NIH goal to develop new vaccines and delivery technologies that allow more complete vaccination coverage. The long-term objective of this research is to develop an oral vaccine that is safe, effective and stable at ambient temperatures, as well as reducing costs of production, distribution and delivery while boosting compliance. The initial focus of this project is for hepatitis B booster treatments for at-risk individuals and poor responders. Plant-based production systems have the potential to meet the goals of the ideal oral vaccine. These have shown great promise in animal trials including the ability of a plant-produced hepatitis B antigen to elicit an immune response in a human clinical trial. However, development of this technology has been limited because of the practical limitations imposed by low expression of the antigen and processing constraints. In Phase I, hepatitis B antigen levels were increased by more than 30-fold and processing methods were established that retained the antigen integrity. This improved material was able to elicit a robust immune response when orally fed to mice. In Phase II, the research is focused on optimizing and characterizing a final product that can be commercialized. This includes 1) optimization and characterization of a high expressing line, 2) a processing method that provides a palatable and stable form of the product, and 3) an immune response in mice so that it elicits a comparable protective response as that of the injected vaccine. Successful completion of Phase II aims will lead to a clinical trial and to a commercialization path with a human health partner.


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: 2014 ( Subtotal = $727,729 )
2014	2014	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVENUE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Allergy and Infectious Diseases Research	000	5	4/10/2014	NON-COMPETING CONTINUATION	$727,729
														Subtotal = $727,729

Issue Date FY: 2013 ( Subtotal = $911,830 )
2013	2013	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVENUE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Allergy and Infectious Diseases Research	000	4	4/12/2013	NON-COMPETING CONTINUATION	$911,830
														Subtotal = $911,830

Issue Date FY: 2012 ( Subtotal = $943,211 )
2012	2012	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVENUE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Allergy and Infectious Diseases Research	000	3	4/26/2012	COMPETING CONTINUATION	$943,211
2012	2012	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVENUE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Allergy and Infectious Diseases Research	001	3	8/8/2012	COMPETING CONTINUATION	$0
														Subtotal = $943,211

Grand Total All Awards = $2,582,770

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An Orally Delivered Booster Vaccine Candidate for Hepatitis B

Award Number: R44AI068239

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: 11/01/2005

PERIOD OF PERFORMANCE END DATE: 04/30/2015

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