Volunteers will be infected with flu, malaria at Melbourne’s new human trials clinic

But influenza is the key focus and inspiration for Doherty Clinical Trials. The respiratory disease, known as the flu, typically kills thousands of Australians each year.

The unit would be the only laboratory in the southern hemisphere conducting human-challenge trials for respiratory pathogens, said Professor Sharon Lewin, director of the Doherty Institute, the organisation focused on infection and immunity.

“We would be investigating novel [new] antivirals for influenza, new vaccine constructs and looking at how effective they are, working in a controlled fashion,” Lewin said.

Influenza is also a prime candidate for the next pandemic. With Victoria’s vaccine capabilities now expanding to allow mRNA vaccine production, McCarthy said it was important to have somewhere to test new formulations.

“We are really worried the next pandemic could be a flu pandemic,” he said.

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“Now with mRNA technologies, we can develop vaccines really quickly … Having a unit like this that can immediately flip to saying, ‘All right, we’re going to test your vaccine’, will really accelerate development of those sorts of things.”

There are careful processes in place to decide which pathogens can be used in human-challenge trials, which are overseen by an ethics committee.

Volunteers at Doherty Clinical Trials can withdraw any time, though they may need to remain in quarantine if they are infectious. They are also paid for their time, at a rate controlled by the ethics committee, often equivalent to the minimum wage.

Most importantly, Brockway said there must always be “rescue medication”. That means viruses such as HIV and Ebola are off the table.

McCarthy said when it came to malaria, for example, doctors could follow the growth of the parasites in the volunteer’s blood with a sensitive DNA test.

“We can actually measure the response before people get sick, and then we can cure them with a licensed antimalarial, so they don’t even [notice the effects of the] malaria.”

McCarthy said that in his previous experience, it was mainly university students who signed up to human-challenge trials because they had more flexible schedules that allowed them to commit to staying in the unit.

“Often around exam time, you’d see them all on their laptops, with the Wi-Fi, doing their assignments and stuff like that,” he said.

Some sign up because they have an interest in health, are studying science or thinking about working in the sector.

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“Then there are obviously other people who say, ‘Well, it would be nice to be in a trial because they’re going to compensate me for my time’. ”

Human-challenge trials were conducted with COVID-19 in the UK in 2021, which attracted plenty of enthusiastic volunteers, but it was not without controversy due to concerns over the coronavirus’s long-term effects.

Doherty Clinical Trials, a not-for-profit enterprise and a wholly owned subsidiary of the University of Melbourne, will conduct research for large pharmaceutical companies as well as for academic groups who would otherwise be unable to fund their trial.

Brockway said this set the unit apart from other commercial units in Australia.

“For all these other clinics, it’s much easier to work on a relatively standard straightforward study from a commercial perspective, but we are actually choosing to do things which are more novel,” he said.

Temporarily located in a building that the state government turned into a back-up intensive care facility during the early months of the pandemic, the unit will eventually find a home at the new Australian Institute for Infectious Disease, due to open in 2027 in Parkville.

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