A vaccine invented at the University of Guelph to protect against Campylobacter jejuni – one of the leading bacterial causes of food-borne illness in the world – has just been approved for human clinical trials by the United States Food and Drug Administration (FDA).
“It’s very rare that you have a discovery go this far,” said Mario Monteiro, chemistry professor. He developed the sugar-based vaccine at the university while working with the U.S. Naval Medical Research Center.
C. jejuni is a leading cause of bacterial diarrhea worldwide. It’s one of North America’s leading bacterial causes of food-borne illness, resulting in 1.3 million cases a year. It occurs at much higher rates in some developing countries and is especially problematic for children.
The bacteria cause ‘traveller’s diarrhea,’ and is associated with irritable bowel syndrome and Guillain-Barré syndrome, a nervous system disorder.
No vaccines exist for the organism. Phase 1 is now in progress and is expected to run until January 2015; human clinical trials can take several years to complete.
“U of G and Dalton Pharma — who manufactured the cGMP grade vaccine — are proud to be part of the Ontario team providing key expertise in biotechnology research and manufacturing,” said David Hobson, manager of technology transfer at the University’s Catalyst Centre.
The vaccine is a conjugate containing polysaccharides from C. jejuni. In a 2009 peer-reviewed study, it proved 100-per-cent effective against diarrheal disease in monkeys.
Dr. Monteiro began collaborating with the U.S. Navy on the vaccine shortly after joining University of Guelph a decade ago.
He studies polysaccharides, or complex sugars, on bacterial surfaces, and is one of the world’s few researchers working on such sugar-based vaccines. He also works on carbohydrate-based vaccines for Clostridium difficile, and collaborated with master’s student Brittany Pequegnat on a carbohydrate-based vaccine against Clostridium bolteae, a gut bug common in autistic children.
“It’s very satisfying that what you do with your hands, with chemistry, can have a positive impact for global health,” he said. “It’s cool – that’s the word I use with my kids in the lab – that something you made, other people want to take it, use it and test it to help people. That’s what I tell my students. It helps keep the excitement going.”
Campylobacter is estimated to cause approximately 1.3 million infections, 13,000 hospitalizations, and 120 deaths each year in the United States.
Source: University of Guelph, adapted