The first human trials of a locally developed COVID-19 vaccine kicked off on Thursday, with South Australian organisation Vaxine the first to reach the major milestone.
The phase one trial will be conducted by the PARC clinical trial unit at the Royal Adelaide Hospital and will involve 40 healthy participants aged between 18 and 65 years who have already been pre-screened.
Speaking to The Australian Financial Review, chairman and research director of Vaxine, Nikolai Petrovsky, said results from the trial, which will focus on the safety and immune response to the COVID-19 vaccine candidate, would be expected within six to eight weeks.
"From there we will look to commence phase two and three trials straight away. The follow-on trials will need to go broader into the elderly and people with chronic disease, because they’re the most vulnerable to COVID infection," Professor Petrovsky said.
"For the final proof [that the vaccine is effective] we're looking at potential countries where we could test the vaccine where there are a lot more COVID-19 cases than Australia.
"From a South Australian perspective in particular, we've been relatively insulated."
As well as looking offshore, Professor Petrovsky said it could be possible to do some phase two and three trials in Victoria, where there has been a spike in COVID-19 cases.
Without the funding to do a wide-scale study with hundreds of thousands of people, a method of doing smaller scale vaccine studies is to "ring fence" an area, in which people in a particular region with a large number of cases are administered the vaccine and its effectiveness is determined by whether or not the virus continues to spread in that area.
Manufacturing particularly and scale-up is expensive, as are large scale clinical trials and ... we’re running on empty.
— Vaxine's Nikolai Petrovsky
Victoria's suburb lockdowns and hotspots will provide a good basis for this type of testing.
Participants in Vaxine's trial will receive two doses of the COVAX-19 vaccine, three weeks apart, or a placebo injection and will then have blood tests to measure protective antibody and T cell responses induced by the vaccine.
Vaxine, while a small company, has 18 years of experience designing vaccines for pandemics and COVAX-19 is modelled off a vaccine the company developed for SARS, which proved effective in animal trials. However, the outbreak was defeated and its funding from the US government was subsequently pulled.
The company is using the recombinant vaccine method. Under this method, researchers insert a virus’ so-called "spike protein" (a major surface protein that allows the virus to take hold in the human body) into a cell in a laboratory.
The cell then grows this protein, but not its genetic material, meaning it takes on the appearance of the virus without actually causing any illness.
The protein is then purified and turned into a vaccine, which triggers a person’s immune response, giving them protection against the real virus.
To date, Vaxine has received about $US50 million ($72 million) in funding from the US government, but Professor Petrovsky said it had received next to nothing from the Australian government.
At the moment, the company is still searching for funding to progress its vaccine candidate into phase two and three trials, which come with a high price tag. It will also need funding to manufacture the vaccine, if its trials are successful.
"Currently we don't have any Australian government funding and our concern is we won't get any going forward. We've had difficulty engaging with the Australian government ... so we're looking overseas," Professor Petrovsky said.
"Manufacturing particularly and scale up is expensive, as are large scale clinical trials and ... we’re running on empty."
The company is looking at manufacturing its vaccine in multiple countries at once, rather than through one large local facility, which could take years to construct.
"You can’t underestimate the complexity of large scale manufacturing of a vaccine," Professor Petrovsky said.
"Typically they’re manufactured in modest amounts because there is a steady amount required year to year. Here, you need a massive amount of vaccine almost instantaneously and to do that is not simple."
Also this month the University of Queensland is expected to commence human trials of its vaccine candidate using its "molecular clamp" platform, which it is developing with help from CSL and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI).
Once the pandemic has been controlled, Professor Petrovsky said it was important for governments internationally to realise that to be adequately prepared to respond to a pandemic, funding for research efforts needed to be consistent.
"What you typically see is you’ll get a pandemic, be it swine flu, SARS or COVID-19, there’s a number of urgent funding initiatives announced and money is thrown out indiscriminately, but then when the crisis is over all that money dries up and you’re back to square one."
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