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University of Sydney to advance SARS-CoV-2 DNA vaccine to human trials
The University of Sydney has announced the commencement of an extended Phase 1 human trial in Australia, evaluating a COVID-19 gene-based vaccine developed by BioNet and Technovalia and delivered via a needle-free system.
Under a $3 million grant from the Australian Medical Research Future Fund (MRFF) Coronavirus Research Response, Associate Professor Nicholas Wood from the University of Sydney, Australia and the National Centre for Immunisation Research and Surveillance will lead a team to evaluate the vaccine candidate for the first time in humans.
This work will be supported by Vax4COVID, an alliance of Australian vaccine clinical trial centres, formed to facilitate the conduct of clinical trials of SARS-CoV-2 vaccine candidates in Australia.
“This phase 1 trial will be the first DNA-based COVID-19 vaccine trial in Australia,” said lead investigator Associate Professor Nicholas Wood.
“It is an excellent partnership with Australian academics, the Vax4COVID Australia Alliance and industry supported by MRFF funding. If the trial indicates the vaccine to be safe then larger phase 2 trials are planned.”
Australian biotech company Technovalia and its international vaccine partner BioNet have developed the gene-based COVID-19 vaccine candidate.
A gene-based vaccine is a new type of vaccine design that uses the genetic (DNA) sequences from the virus. Researchers identify and isolate parts (genes) of the virus genome most suitable for use for the vaccine.
“In the case of COVID-19, the gene that codes for the coronavirus spike protein has been selected for the vaccine,” said Associate Professor Wood.
“The delivery is via a needle-free device which penetrates the skin with a jet spray. This is designed to make sure the DNA vaccine gets inside the cells to encourage good uptake by the immune system. Once the DNA is inside the cell, the body uses the DNA (its) code to make the coronavirus spike protein. This should then trigger an immune response that we hope will be strong enough to ‘remember’ and protect against future virus infection,” he said.
Preclinical studies in animals have shown that the gene-based vaccine is safe and immunogenic. The next step is to test the vaccine in humans. With the support of the Australian Government, Associate Professor Wood will lead the clinical evaluation of this recombinant vaccine against COVID-19 in three states across Australia.
There are several candidate DNA vaccines against COVID-19 in development some of which are currently being tested in clinical trials in the US, Japan and South Korea.
About the trial
This phase 1/1b, multi-centre, observer-blinded, dose-ranging, randomized, placebo-controlled trial will assess the safety, reactogenicity and immunogenicity of different doses of the vaccine given to healthy participants aged 18 to 75 years old in three states (NSW, SA and WA) across Australia.
As a phase 1 trial, the key goal is to examine the safety of two doses of the vaccine given one month apart. If the trial is successful, then a phase 2 trial will be undertaken in a larger number of participants.
Through this network of key experts and partners, this collaborative approach promises to accelerate the development of and access to this COVID-19 candidate vaccine in Australia.