Led by the Doherty Institute of Infection and Immunity, and with start-up funding from the Victorian Government Department of Health and Human Services, Vax4COVID is an alliance of Australian vaccine clinical trial centres, with extensive experience and expertise in the conduct of vaccine clinical trials, including pandemic viral vaccines, formed to facilitate the conduct of Phase II trials of SARS-CoV-2 vaccine candidates in Australia.
Trials in Healthy Adults and the Elderly
Thousands of healthy adult and elderly volunteers will be required to participate in high quality human clinical trials of the promising COVID vaccine candidates that have passed exhaustive pre-clinical (animal and laboratory) testing. As part of an ‘all-stops out’ approach, Phase I (preliminary tolerability and dosing) and Phase II studies (definitive dosing, scheduling and more safety checking) must still be conducted in countries that have good control of circulating COVID disease. Subsequent Phase III studies should be undertaken, by contrast, in countries with high levels of circulating COVID to see if the trial vaccines actually prevent disease. Australia is ideally placed to conduct Phase I and Phase II COVID vaccine clinical trials.
Alliance Centres and Supporting Institutions
Scanning electron microscope image shows SARS-CoV-2 (round blue objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. Source: NIH (NIAID).