Coronavirus: Human trials begin in search for vaccine

The first human trials of a COVID-19 vaccine in Australia have officially begun.

The first human trials of a COVID-19 vaccine in Australia have officially begun, with volunteers injected with a vaccine candidate developed by US company Novavax.

The vaccine candidate is a protein recombinant vaccine, created with nanoparticle technology, and contains an adjuvant known as Matrix X to enhance the immune response.

Its development has been funded with $388m from the Coalition for Epidemic Preparedness.

The phase 1 trial, which started in Melbourne on Tuesday, is being conducted by the Australian human trials organisation ­Nucleus Network, with 131 people participating. Ten other human trials are under way internationally.

Novavax chief scientific officer Gregory Glenn said if phase 1, 2 and 3 trials proved successful, the company would be ready to move into manufacture. He said it was hoped the vaccine would work by stimulating the production of neutralising antibodies. “We take the sequence of a gene, we make that protein like a 3D printer, and that becomes our vaccine,” Dr Glenn said. “We add an adjuvant, which plays a role to stimulate a much stronger immune response to that protein. Together that results in highly functional response.

“One of the features of our vaccine is we can use very low doses. What that allows us to do is make a lot of doses.”

All that would be dependent on the results of human trials. Ninety per cent of vaccine candidates fail before phase 3 trials succeed. The human trials of Novavax’s candidate are in Melbourne and Brisbane. Participants are aged 18 to 59 and all have been screened for any health conditions.

Nucleus Network has been chosen because of its expertise as a phase 1 clinical trials company.

“As Australia’s largest phase 1 clinical trials specialist, we have a rich history of delivering phase 1 vaccine trials, and a long-standing track record with Novavax,” ­Nucleus Network infectious diseases physician and microbiologist Paul Griffin said. “This trial offers the first critical step into creating a ­potential vaccine that is safe and able to be accelerated into the next phase of development.”

There are extensive safety measures in place to cover clinical operations and participant recruitment, Nucleus Network CEO Cameron Johnson said.

“For all of our clinical trials, Nucleus has implemented the highest level of transmission-based precautions within its clinical units including the creation of dedicated teams of clinical staff,’’ he said.

“The decision by Novavax to select Nucleus Network is a significant milestone for the Australian clinical trials ecosystem. We have a long way to go, but we’re proud to be a part of the team to deliver a safe, effective, and accessible vaccine as quickly as possible.”