The University of Sydney, Technovalia and Vax4COVID have announced ethics approval has been granted for an Australian phase one clinical trial of the COVIGEN COVID-19 vaccine candidate.
Melbourne-based Technovalia is a privately-owned Australian biotechnology company focused on the research and development of innovative vaccines and diagnostics.
The vaccine will be tested in around 150 participants aged aged between 18 and 75 at sites across three Australian states (NSW, SA, and WA). The sites are operated by Vax4COVID.
Led by the Doherty Institute of Infection and Immunity, Vax4COVID is an alliance of Australian vaccine clinical trial centres formed to facilitate the conduct of trials of COVID-19 vaccine candidates.
The screening and enrolment of participants for the ‘COVALIA’ trial are expected to commence this month.
The University of Sydney said the goal of the trial is to assess the safety, reactogenicity and immunogenicity of different doses of COVIGEN. Participants will be administered two doses one month apart. The university said a phase two trial will be initiated if the candidate successfully navigates phase one.
The trial’s lead investigator, Associate Professor Nicholas Wood, is based at the University of Sydney Children’s Hospital Westmead Clinical School.
“We are excited to start enrolment along with our colleagues in Perth and Adelaide, and to undertake the first needle-free COVID vaccine trial in Australia,” said Associate Professor Wood. “The start of the COVALIA study is a significant milestone for all involved in this one-of-a-kind partnership between Australian institutions, the industry and the Australian government via the Medical Research Future Fund (MRFF).”
“We are very pleased that the COVALIA trial received the green light to start recruiting in the coming weeks. This is the result of a global partnership which started in 2020 with the COVIGEN project,” said Laurent Dapremont, the CEO of Technovalia.
“We believe nucleic acid vaccines will play an important role to combat the pandemic, especially with the emergence of new SARS-CoV-2 variants, and we are looking forward to working with all our partners to bring and produce in Australia this COVID-19 DNA-based vaccine.”