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The University of Sydney is testing a novel DNA-based COVID-19 vaccine – under a $3 million grant from the Australian Medical Research Future Fund (MRFF) Coronavirus Research Response – with the goal of being administered using a needle-free system.
The University of Sydney is announcing 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.
“This phase 1 trial will be the first DNA based COVID vaccine trial in Australia,” said lead investigator Associate Professor Nicholas Wood from the University of Sydney’s Faculty of Medicine and Health.
“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.
“In the case of COVID-19, the gene codes for the coronavirus spike protein have been selected for the vaccine. Once the DNA is inside the cell, the body uses the DNA code to make the coronavirus spike protein and this should then trigger an immune response that we hope will be strong enough to ‘remember’ and protect against further virus infection,” said Associate Professor Wood, who is also from the National Center for Immunization Research and Surveillance.
“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.”
While still subject to approval in Australia, the delivery device is used in vaccination programs in the United States.
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.
This work is supported by Vax4COVID, an alliance of Australian vaccine clinical trial centers, formed to facilitate the conduct of clinical trials of SARS-CoV-2 vaccine candidates in Australia.
Co-Investigator Professor Helen Marshall from the Robinson Research Institute, The University of Adelaide and Women’s and Children’s Hospital, Adelaide, and a VAX4COVID investigator, said “This trial will be an ideal opportunity for Australians to be involved in a COVID-19 vaccine trial using a needleless device to deliver the vaccine, a device that is already being used to give flu vaccines in the US. Through strong partnerships between Government, academia and industry we are well placed to deliver COVID-19 vaccines to the Australian people, should it prove to be effective.”
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