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.”