Progress 06/01/15 to 01/31/16
Outputs
Target Audience:The target audiences of this NIFA SBIR Phase 1 program are all animal health companies and poultry producers who work to control the disease of avian coccidiosis. These groups will benefit from an orally delivered anticoccidiosis poultry vaccine such as the one being developed by US BIOLOGIC and the ARS. This vaccine can be easily distributed to large groups of birds across multiple flocks using existent water delivery systems. Further, this vaccine avoids the use of live parasites to enhance the immune response, as well as the overuse of use antibiotics, which can lead to antimicrobial resistance challenges. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?
Nothing Reported
How have the results been disseminated to communities of interest?These results will be disseminated via technical reports, poster presentations, peer-reviewed journal articles, and in book chapters, as appropriate and as allowed by intellectual property regulations and procedures. These results further will be shared through private communications with additional public and private partners. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
What was accomplished under these goals? Poultry coccidiosis is a global food animal health problem and can cause market disruption and food shortages. Poultry producers utilize several methods, including flock maintenance, culling, and prophylactic medications such as antibiotics and ionophores. However, the use of prophylactic medications has been slowed by continued market and regulatory pressures. At the same time, discontinuing use of prophylactic medications will cause poultry disease prevention gaps across the U.S. In response, US BIOLOGIC and the USDA Agricultural Research Service are developing a cost-efficient, safe, and effective anticoccidial vaccine solution comprised of three vaccine candidates that avoid the use of live parasite vaccines and antimicrobial resistance issues. The base bacterial carrier can be expanded to include other forms of avian illnesses (e.g., avian influenza). The results of this Phase 1 trial (in silico, in vitro, in vivo) have shown a clearly encouraging opportunity. Partners and Tasks The USDA Agricultural Research Service (ARS) has developed and proven via needle inoculation three promising candidate vaccines: NK-lysin, cNK-2, and 3-1e. US BIOLOGIC's platform oral delivery technology now allows for an efficient oral-delivery method. Through this Phase 1 NIFA SBIR program, USDA ARS and US BIOLOGIC each contributed significantly. Both partners led study design and data analysis. US BIOLOGIC performed all in silico and in vitro work. The ARS performed all in vivo work. Broader Outcomes A successfully commercialized product would offer a transformative tool for poultry farmers to limit destruction caused by coccidiosis, encouraging better food security, and limiting threats from bioterrorism. Further, the platform technology being developed may be used to implement a range of orally delivered vaccines created out of either newly available antigens or antigens currently available on the market. Peripherally, this platform technology also may be developed for human use. Research Results All in silico and in vitro tasks were completed successfully with promising results. Clinical Trial Summary The 3-1e vaccine performed well on all clinical measures. The second two vaccine candidates elicited opportunities for innovation. Patents Several patents have resulted from this Ph1 opportunity. Change in Knowledge Through this program, the partners created methods/techniques applicable to the oral-delivery platform, including the placement of the candidate vaccines into the context of the platform. Further, the partners refined the vaccine dosage, etc., which will impact cost-of-goods and ultimate market viability globally and allows for increased knowledge for future commercialization decisions. Change in Action US BIOLOGIC's work in this Phase 1 NIFA SBIR will affect several areas of application and actual use of fundamental or applied knowledge of the oral-delivery platform and the vaccines. Change in Condition The fundamental change in condition is the potentially higher yields of poultry in the U.S. and globally as the vaccine reduces the level of sub-disease coccidiosis that will in turn reduce the number of gut lesions in poultry that receives the vaccines. The ability of the birds to consume more feed in a shorter amount of time could result in better profits for poultry makers, better availability of protein to the consumer, and lower costs of poultry meet globally. These changes in turn improve food safety for several populations that will now have better access to poultry protein. A second fundamental change in condition will be the reduction of antimicrobial resistances present in the current production facilities for poultry that is concurrent with the reduced need/use of prophylactic antibiotics. The reduction of these resistant microbials will lend itself to overall gut health. Also, the reduction of these resistances could allow concurrent use of targeted antibiotics to further reduce disease in the poultry.
Publications
|