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Bioniche E. coli 0157 Vaccine Shows Further Promise in Controlled Challenge Study

Bioniche Life Sciences Inc., a fully-integrated human and animal health biopharmaceutical company, today announced that a controlled challenge study, performed at the Vaccine & Infectious Disease Organization (VIDO) at the University of Saskatchewan, has again demonstrated the efficacy of the E. coli 0157 cattle vaccine developed by the Company’s Food Safety division in partnership with VIDO, the University of British Columbia, and the Alberta
Research Council. Two commercial scale vaccines were evaluated in the study: one using the Bioniche manufactured vaccine and the other using a vaccine produced by the Alberta Research Council – Biologics fermentation facility.


Seventy-two (72) animals were vaccinated three times each, at three-week intervals, followed by a single, orally-administered challenge with 1×10(9) or one billion E. coli 0157 bacteria two weeks following the last vaccination. Vaccine efficacy was evaluated by observing the total bacteria shed in manure and the number of animals shedding the bacteria following vaccination. Both vaccines demonstrated significant effectiveness and the most effective commercial-vaccine formulation resulted in a 99.56% or 2.35 log reduction in the amount of bacteria shed, and a 70% reduction in the number of animals shedding.
“These results are very encouraging,” said Dr. Dragan Rogan, Vice-President, Research and Development at Bioniche Life Sciences Inc. “This challenge model uses a far greater number of bacteria than would ever be encountered by cattle in the farm or feedlot situation. For the vaccine to reduce shedding of E. coli in the manure after such a high dose of bacteria is further confirmation of the commercial potential of this technology. These results confirm previous vaccine efficacy feedlot field challenge studies completed by the University of Nebraska over the last two summers.”
Feedlot cattle vaccinated with the E. coli 0157 vaccine in research studies during the summers of 2002 and 2003 showed a significant reduction of the deadly bacteria in their manure. Vaccination of cattle in the University of Nebraska research feedlot reduced E. coli prevalence an average of more than 80% compared with unvaccinated cattle.
Bioniche is the commercialization and marketing partner in a strategic alliance with the University of British Columbia, the Alberta Research Council, and the Vaccine & Infectious Disease Organization at the University of Saskatchewan. “This strategic partnership has developed an E. coli 0157 vaccine candidate that is consistent, efficacious, and commercially viable,” said Martin Warmelink, President of Bioniche Food Safety. “These new data will be submitted to the regulatory agencies in both Canada and the United States as part of our ongoing regulatory and commercial development process.”

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