COVID-19 vaccine trial to commence in Perth

Linear Clinical Research, a subsidiary of the Perth-based Harry Perkins Institute of Medical Research, has been selected to conduct a human trial of a vaccine candidate that should help the body produce antibodies to fight SARS-Cov-2, the deadly coronavirus that causes COVID-19.

COVID-19 S-Trimer has been developed by global biotechnology company Clover Biopharmaceuticals, based in China, and is said to be one of the first vaccine candidates in the world to demonstrate safety and immune response against COVID-19. Clover was one of the first companies to start developing a COVID-19 vaccine — having begun work in January this year — and its access to early COVID-19 data and reagents meant it was one of the first to develop a vaccine candidate that targets a protein that the virus needs to enter host cells.

According to Linear CEO Jayden Rogers, what makes the vaccine candidate so promising is Clover’s Trimer-Tag technology platform, which is used to create the protein-based COVID-19 S-Trimer vaccine that aims to promote production of antibodies against the coronavirus Spike (S) protein.

“Clover’s Trimer-Tag platform has already been used in a range of clinical studies and has also been utilised for the development of vaccines for other RNA-based viruses such as influenza, RSV and HIV,” Rogers said.

“Combined with extensive preclinical research and commercial-scale manufacturing capabilities, COVID-19 S-Trimer is one of the most exciting vaccine programs globally for the current coronavirus pandemic.”

The vaccine is also one of the first to make it to human trials, with the Phase 1 clinical trial planned to involve healthy adult and healthy elderly trial participants; if successful, a larger Phase 2b/3 clinical trial involving thousands of people around the world would be conducted immediately. There are currently more than 60 candidate COVID-19 vaccines in development, but only a few are entering early clinical trials in human volunteers.

“Linear was awarded the study because of our extensive experience testing the world’s latest medical breakthroughs combined with its industry-leading digital innovations,” Rogers said.

“We are fortunate to be one of the few countries in the world to still be offering functional clinical trial facilities because we do not have large volumes of COVID-19 cases as compared to other parts of the world.”

The vaccine program has already expanded to include innovations from renowned global vaccine development experts including GSK, Dynavax and the Coalition for Epidemic Preparedness Innovations (CEPI). Linear will be seeking volunteers to participate in the study within the next two months.

Separate to this, researchers from CSIRO have developed a novel visualisation platform, underpinned by bioinformatics algorithms originally used to analyse the human genome, to pinpoint differences among the thousands of genetic sequences of SARS-CoV-2. Published in the journal Transboundary and Emerging Diseases, their work should help researchers better understand how strains of the virus evolve and help identify new clusters of the virus.

CSIRO Chief Executive Dr Larry Marshall said knowing the virus’s genetic code was vital, stating, “The more we know about this virus, the better armed we’ll be to fight it.

“This highly complex analysis of the genome sequence of the SARS-CoV-2 virus has already helped to determine which strains of the virus are suitable for testing vaccines underway at the Australian Centre for Disease Preparedness in Geelong — the only high biocontainment facility of its kind in the Southern Hemisphere.”

CSIRO’s Bioinformatics Team Leader, Dr Denis Bauer, said as the virus evolved the blueprint becomes increasingly important, effectively because it holds instructions about the behaviour of the virus and what kind of disease it can cause.

“Globally there is now a huge amount of individual virus sequences,” Dr Bauer said.

“Assessing the evolutionary distance between these data points and visualising it helps researchers find out about the different strains of the virus — including where they came from and how they continue to evolve.”

CSIRO’s Dangerous Pathogens Team Leader, Professor SS Vasan, is leading the SARS-CoV-2 virus work and vaccine evaluation studies and is the corresponding author of the paper. He said the first 181 published genome sequences from the current COVID-19 outbreak were analysed to understand how changes in the virus could affect its behaviour and impact.

“This RNA virus is expected to evolve into a number of distinct clusters that share mutations, which is what we have confirmed and visualised,” Prof Vasan said.

“At this time, we do not expect it will affect the development and evaluation of COVID-19 vaccines, therapies and diagnostics, but it is important information to monitor as preclinical and clinical studies progress.

“To enable this, we are calling on the international research community to share de-identified details of case severity and outcome, and other relevant meta-data such as co-morbidities and smoking status, alongside the genomic sequences of the virus.”

“The advantage of the data visualisation platform is that it highlights evolving genetic mutations of the virus as it continues to change and adapt to new environments,” Dr Bauer said.

“The more informed we are about the genetic differences and their likely consequences on the progression of the disease, the better we can tackle the disease with diagnostics and treatments.”

The COVID-19 genome visualisation platform can be found here.

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