An Orally Delivered Booster Vaccine Candidate for Hepatitis B

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,582,770.00
Award Year:
2012
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI068239-03A1
Award Id:
n/a
Agency Tracking Number:
R44AI068239
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-123
Small Business Information
CAL POLY Technology Park, Bldg. 83 Space 1D, SAN LUIS OBISPO, CA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
176532203
Principal Investigator:
JOHN HOWARD
(805) 756-6458
jhoward@appliedbiotech.org
Business Contact:
JOHN HOWARD
(805) 756-6458
jhoward@appliedbiotech.org
Research Institute:
Stub




Abstract
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 asthere 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 stableat 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 theinjected vaccine. Successful completion of Phase II aims will lead to a clinical trial and to a commercialization path with a human health partner. PUBLIC HEALTH RELEVANCE: The relevance of this project to public health is that it can lead to aninexpensive, stable, and effective oral vaccine for hepatitis B. Such a vaccine can be used for at-risk individuals who respond poorly to the current vaccine and in developing areas where the current vaccine is unavailable due to cost constraints. This research may also pave the way for other vaccines to be administered in a similar fashion.

* information listed above is at the time of submission.

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