An international collaboration involving researchers at the University of Alberta and Griffith University in Australia has launched the first phase of human clinical trials for a potential strep A vaccine.
Group A streptococcus bacteria, more commonly known as strep A, kills more than 500,000 people a year, and there's currently no vaccine. Strep A can trigger a variety of severe diseases and conditions including rheumatic fever and necrotizing fasciitis (flesh-eating disease). It can also cause a handful of neurological conditions, explains Lawrence Richer, including Sydenham chorea, a disorder typically affecting children that is characterized by constant movement and can be extremely debilitating. Children and marginalized populations are disproportionately affected by strep A infections.
"The potential to have a vaccine that prevents those things would be a huge win for young people and adults alike," says Richer, centre director of the Northern Alberta Clinical Trials and Research Centre, professor in the Department of Pediatrics and member of the Women and Children's Health Research Institute.
The collaboration began when Distinguished Professor Lorne Tyrrell and Nobel laureate Sir Michael Houghton from the Li Ka Shing Applied Virology Institute heard of Michael Good's group A strep vaccine program at Griffith. Good is an adjunct professor in the Department of Medical Microbiology and Immunology at the U of A.
"I was aware of vaccine activities ongoing elsewhere on this nasty bug and thought that Michael's strategy was innovative," says Houghton.
Researchers at Griffith created the vaccine by combining two molecules found on every strain of strep A — an approach they hope can enhance the body's immune response against all strains.
Tyrrell and Houghton decided the facilities and infrastructure at the U of A made it the perfect spot to launch a trial for the vaccine, and through the Li Ka Shing Applied Virology institute, they funded the first stage of clinical trials, with Griffith holding the intellectual property.
According to Richer, the trial builds on many years of investment in early-phase clinical trials and facilities for Phase 1 research at the U of A: "It's really an ideal circumstance for these types of trials to be done under the safest conditions possible."
While the trial is a collaborative international effort, Richer notes the infrastructure available through NACTRC, Alberta Health Services and the U of A is integral for supporting researchers at the university.
"We as an institution are innovating constantly. Our own investigations are deriving new ideas to treat diseases, new vaccines," he says. "It struck me — why would we ask our investigators to go somewhere else to do these trials?"
Expertise in launching trials also helps researchers overcome a major barrier in translating their work, as it can be extremely challenging to take innovations from the laboratory to human trials, explains Richer. "It's hard. There are risks to humans, it can be expensive, it takes infrastructure, it takes support, it takes knowledge."
The objective of this Phase 1 clinical trial, which Richer estimates will include 10 to 20 patients, is to first demonstrate safety, and then efficacy. If successful, the Li Ka Shing Applied Virology Institute plans to support Phase 2 trials, which involve a larger number of patients.
