A human trial has been launched into the University of Queensland's (UQ) second generation COVID vaccine, more than two years after the original technology was abandoned amid patients falsely testing positive to HIV.
UQ scientists have re-engineered the molecular clamp technology and need 70 healthy volunteers aged 18 to 50 to test its effectiveness as a COVID vaccine compared to the approved Novavax shot.
Although the trial will assess the technology – dubbed Clamp2 — as a COVID vaccine, the researchers say if it's successful, it's more likely to be used to protect people during future pandemics and in jabs for existing viruses, such as respiratory syncytial virus (RSV).
Project leader Keith Chappell said the scientists were working on using the technology to create vaccines for "a range of viruses".
"Our primary purpose is not to bring another COVID vaccine to market," Associate Professor Chappell said.
"The vaccines that are out there are working extremely well and keeping a lot of people out of hospitals.
"This isn't going to be the last time the world faces a pandemic and next time around, we want to … make sure there are doses available as quickly as possible and they're safe, and they can protect Australians and people around the world.
"If we can show that this technology is safe and that it's effective, the next time around we can ramp up extremely quickly and get vaccines to the people that need them in an emergency."
Professor Chappell said he was "extremely confident" in the potential of Clamp2.
"I hope to one day save some lives and produce a vaccine that can make a difference," he said.
What's changed since last time?
The original clamp technology contained two fragments of a protein found in HIV, which acted like a chemical bulldog clip, holding together an engineered version of the spike protein found on the surface of SARS-CoV-2, the virus that causes COVID-19.
That worked by allowing the immune system to recognise – and attack – the spike protein, producing protective antibodies.
On its own, the SARS-CoV-2 spike protein is unstable. It needs to be locked into shape to ensure the vaccine produces a robust immune response.
But the molecular clamp used in the original UQ vaccine also resulted in people falsely testing positive to HIV, causing it to be dramatically abandoned.
Professor Chappell said the fragments of protein in HIV had been replaced by a "small amino acid sequence with similar properties" in Clamp2.
He could not reveal more details because of intellectual property protections.
"We had to go right back to square one to define something that had the right properties to be a molecular clamp," Professor Chappell said.
"We also had to completely redefine how we manufactured this vaccine because we were using a specific purification methodology that would purify the original molecular clamp.
"Not only did we need to change the molecular clamp, we needed to change the purification methodology. We now have that working extremely well."
The molecular virologist said vaccines using the UQ technology would have benefits over existing technology, once licensed by medicine regulators.
"They'll be cheaper, they can get to regions of the world that are resource-limited and also have the stability to be able to be shipped around the world without having to be frozen at extremely low temperatures," Professor Chappell said.
"The biggest benefit in terms of pandemic preparedness is that it can be rapidly scaled up into millions and millions of doses."
Researchers seeking trial participants
Professor Chappell said volunteers wanted for Clamp2's first human trial need to have received a COVID vaccine, but not in the past three months.
They also cannot have contracted SARS-CoV-2 in the past three months.
"There are no overnight stays required and participants will be reimbursed for their time," he said.
The Coalition for Epidemic Preparedness Innovation (CEPI) is providing up to $8.5 million to support further development of the UQ technology for use in the global response to future disease outbreaks.
Nucleus Network will conduct the trial in Brisbane. Half the participants will be given one dose of the UQ vaccine and the rest will receive Novavax's COVID shot.
They will be monitored for six months.
Visit nucleusnetwork.com/UQ for information about participating in the trial.
