Australia’s first needle-free, gene-based COVID-19 vaccine study will be spearheaded in Western Australia by researchers from The University of Western Australia and Telethon Kids Institute.
The $6 million trial, announced by Minister for Health, The Hon Greg Hunt, named Telethon Kids Institute as one of Australia’s most experienced vaccine trial sites and one of four locations chosen to participate in Phase 1 of the study.
Only the fifth DNA vaccine to enter clinical trials worldwide, and the first one in Australia, the COVIGEN COVID-19 vaccine study will begin by early December and evaluate safety and effectiveness when given to healthy adults.
Led by The University of Sydney and the Vax4COVID Alliance, the vaccine will be tested in three states across Australia (NSW, SA, and WA).
UWA Professor Peter Richmond, Head of the Vaccine Trials Group at the Wesfarmers Centre of Vaccines and Infectious Diseases and based at the Telethon Kids Institute said the study provided an exciting opportunity to accelerate the development of a promising COVID-19 vaccine.
“The COVIGEN vaccine uses a needle-free system that delivers the DNA for the COVID-19 spike protein through the skin,” Professor Richmond said.
"This technology is already being used for influenza vaccines in the USA and has been shown to be safe and stimulate protective antibodies.”Professor Richmond
Australian biotech company Technovalia and its international vaccine partner BioNet have been actively developing gene-based COVID-19 vaccine candidates since March 2020, with preclinical studies already confirming the safety and immunogenicity of COVIGEN.
Professor Richmond said the clinical trial would include both younger and elderly adults, the latter known to be at highest risk for severe COVID-19 disease.
“This first phase of the study will involve 150 adults of all ages, with participants receiving two doses of COVIGEN, given one month apart,” Professor Richmond said.
“If successful, a second and third phase of the study will be undertaken with a larger number of participants.”
“The results will then be used to inform government vaccination policies and provide essential safety information ahead of a potential Australia-wide COVID-19 vaccine roll-out.”