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The everyday Australians taking part in a human trial of a coronavirus vaccine - ABC News

Earlier this year, when authorities were bracing for the worst-case scenario of the coronavirus pandemic in Australia, Perth-based data analyst Rachelle Kalic was crunching the numbers.

The 35-year-old started her own Excel spreadsheet, mapping out how many hospital beds were available in the city.

"I tried to understand what could potentially happen and what has been happening," Ms Kalic said.

While Western Australia has so far managed to maintain low case numbers, Ms Kalic still felt the effects of the virus.

"My dad is an Uber driver and so he saw his source of income just dry up. He's actually on JobKeeper at the moment," she said.

After hearing about a call out for volunteers for one of the world's first human trials of a vaccine for COVID-19, Ms Kalic put her hand up.

"The reason I wanted to do it is because I think that developing a vaccine is probably the only way that we're going to be able to go back to normal," she said.

Rigorous selection process

A team of medical researchers gather around hospital beds with folders and paperwork, speaking to trial participants.
The Linear research team speak to participants in the COVID-19 vaccine trial on the day they are dosed.(ABC News: Will Storey)

7.30 was granted exclusive access behind the scenes of the phase 1 trial of a COVID-19 vaccine candidate, which is being conducted by clinical research company Linear at the Queen Elizabeth II Medical Centre in Perth.

The 150 volunteers who are chosen to be injected with the trial vaccine need to be fit and healthy and pass several medical tests.

Inside the Harry Perkins Institute of Medical Research building, the Linear screening team take blood samples, check BMIs and the volunteers' medical history.

There is no shortage of volunteers, each with their own reasons for putting their body on the line.

Linear CEO Jayden Rogers stands in a corridor in the screening facility in Perth wearing a suit and glasses.
Linear chief executive Jayden Rogers says the COVID-19 vaccine trial is a major coup for Western Australia.(ABC News: Glyn Jones)

The rigorous screening process began last month, with Linear chief executive Jayden Rogers saying the entire trial had been fast-tracked.

"I think everyone would agree it's been a hectic pace ever since we all first learnt of COVID-19," Mr Rogers said.

The vaccine candidate being trialled by Linear is called SCB-2019 and was developed by Chinese company Clover Biopharmaceuticals.

Lara Hatchuel looks at the camera inside a medical ward where they are conducting a trial.
Linear's associate medical director Lara Hatchuel is monitoring the safety of the clinical trial of the COVID-19 vaccine candidate.(ABC News: Marcus Alborn)

This trial vaccine is a synthetic form of the spike protein of the COVID-19 virus. These spike proteins around the outside of the virus allow it to invade human cells.

"The intention is then to mount a strong immune response so that if you are ever infected with COVID-19, your body knows exactly how to deal with it," Linear associate medical director Lara Hatchuel said.

"This is one of those lifetime career goals, to be able to contribute to such an important and exciting trial that has this global impact," she said.

The first dose

Rachelle Kalic sits on a hospital bed in a black t-shirt waiting to be dosed with a vaccine.
Rachelle Kalic said the vaccine trial is a "momentous thing".(ABC News: Marcus Alborn)

An atmosphere of anticipation pulses through the ward as the Linear team prepares to dose the participants with the trial vaccine for the first time.

Before their injections, the participants are swabbed to ensure they do not already have COVID-19, and then undergo another series of blood tests.

Every step of the trial is under intense scrutiny from regulators, so there is no room for mistakes.

Ms Kalic successfully made it through the screening process and is officially part of the trial.

Some of the candidates receive a placebo.

"The investigator, the study teams, the clinic team and the participant are not aware of whether they've received placebo, or the vaccine itself," Dr Hatchuel said.

20-year-old Benjamin Bruce sits on a hospital bed wearing jeans and a t-shirt.
Benjamin Bruce volunteered for the trial because he wants to help vulnerable people, like his grandparents.(ABC News: Marcus Alborn)

Fly-in-fly-out worker Benjamin Bruce, 20, has also made it onto the trial and said he volunteered out of concern for the impact of COVID-19 on elderly Australians.

"I have elderly grandparents myself, and I know they're a high-risk factor of the population. So I'd love there to be a vaccine that could protect them," Mr Bruce said.

Mr Bruce and the others on the trial will be compensated up to $2,350 for their time. It is a two-year commitment and there are plenty of rules.

"No recreational drugs, no excess drinking, no drinking before dosing," Mr Bruce said.

"You can't exercise too much either when you're doing the trial. You have to limit strenuous exercise."

The vaccine landscape

A Linear researcher works on some samples in the lab wearing a white coat and glasses.
A Linear researcher works on samples in the lab.(ABC News: Glyn Jones)

According to the World Health Organization, there are now 17 vaccines that have reached the clinical evaluation stage, and more than a hundred that are pre-clinical.

Damian Purcell, an infectious diseases expert at the Peter Doherty Institute for Infection and Immunity, said it was a good thing to have so many vaccine candidates.

"I think we're looking at probably a faster time frame if everybody shares the information and openly compares the results," Professor Purcell said.

"To be clear, the clinical trial stages for most of these is at the stage of understanding safety. We won't be able to tell anything at the moment about their efficacy."

Professor Purcell said the Clover vaccine candidate being trialled by Linear was one of the vaccines picked out by the Coalition for Epidemic Preparedness Innovations (CEPI) as "a winner".

"Clover's vaccine is similar to several others, including the one developed by the University of Queensland," he said.

"These things are likely to be safe. I think they're very strong candidates."

The Linear trial in Perth is looking at the safety aspect but also the immune response the body produces.

"Any drug development is an inherently tricky process and unfortunately, more will fail than succeed," Linear's Mr Rogers said.

"At this stage, the data's looking positive in preclinical models. It's a very rigorous trial design that the company has chosen."

Checking for symptoms

Rachelle Kalic sits at her kitchen table and takes her temperature using a thermometer and recording the results on her phone.
Rachelle Kalic checks her temperature as part of the vaccine trial, using a thermometer and a phone app.(ABC News: Marcus Alborn)

For a week after they receive the vaccine candidate, the trial participants are asked to monitor their symptoms.

This includes taking their temperature in the evenings and filling out an electronic diary which is analysed by the Linear team.

Neither Ms Kalic nor Mr Bruce showed any signs of a fever, cough, muscle soreness or other symptoms throughout the week, or at their check-up back at the clinic.

"I feel fine, I feel completely normal," Ms Kalic said.

"There's no pain, there's no swelling, I feel fighting fit."

Each of the participants will receive a second dose of the trial vaccine 21 days after their first injection.

Small glass bottles containing the vaccine are on a metal tray.
The trial vaccine was developed by Chinese company Clover Biopharmaceuticals.(ABC News: Glyn Jones)

The next phase of the trial would see thousands of participants take part across the world.

"I think this is something we'll look back on with a lot of pride. But at the moment, we're just focused on doing what we need to do," Linear's Mr Rogers said.

"Even if this isn't the successful COVID-19 vaccine candidate, at least then we'll have learned something about it," Ms Kalic said.

"It's such a momentous thing. It would make such a difference for so many people."

Watch this story tonight on 7.30.

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2020-07-05 21:43:13Z
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