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.
Under a $3million grant from the Australian Medical Research Future Fund (MRFF) Coronavirus Research Response, Associate Professor Nicholas Wood from the University of Sydney, Australia and will lead a team to evaluate the vaccine candidate for the first time in humans.
“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 Centre for Immunisation 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.
This phase 1 trial will be the first DNA based COVID vaccine trial in Australia
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 centres, 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.”
The gene-based vaccine vial in the filing line. Supplied by Bionet.
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 and access to this COVID-19 candidate vaccine in Australia.
The Vax4COVID specialised expertise focuses on rapid planning, recruitment, ethics and genetically modified organism (GMO) approvals, and execution of SARS-CoV-2 vaccine trials in healthy individuals and/or at-risk populations, including healthcare workers and older adults, with the capacity to pre-recruit cohorts of interested individuals.
“This project embodies the important role the University of Sydney’s health and medical researchers play in rising to the health challenges of our time. In what has been a difficult year, it is the collaborations between our leading scientists and industry, such as this, that will provide the solutions and pave the way forward,” said Professor Duncan Ivison, Deputy Vice-Chancellor (Research) at the University of Sydney.
Mr Laurent Dapremont, Chief Executive Officer of Technovalia said: “We are very pleased and proud to be able to contribute to the development of an effective solution to the crisis we have been living for many months. This is a unique collaborative effort with outstanding partners and clinicians, and most importantly, plans are being put in place with BioNet and LuinaBio to rapidly develop a vaccine againstCOVID-19 which can be produced in Australia.”
Dr Pham Hong Thai, Chief Executive Officer of BioNet-Asia, said: “We are glad to continue our collaboration with Technovalia as this is the second vaccine to be evaluated in Australia, first Pertagen® and now this vaccine, two recombinant vaccines against highly contagious respiratory diseases, respectively pertussis (whooping cough) and COVID-19. We are also delighted to join A/Prof. Wood and his colleagues from Vax4COVID in the fight against the COVID-19 pandemic in Australia.”
Declaration: The researchers declare no competing interests. Collaborator Dr Anita Van Den Bigellaar from the Telethon Kids Institute is an advisor to Technovalia.