Since the start of the pandemic, finding a vaccine has been described as the ultimate weapon against COVID-19, and the best route back to a normal life. However, with this process normally taking up to 10 years, it is still uncertain when an effective vaccine may become available. Associate Professor Paul Griffin, Infectious diseases expert with Australia’s largest Phase 1 clinical trials specialist, Nucleus Network, has been involved in Australia’s first human trials for a COVID-19 vaccine and explains what is involved.
“There are four main ways to make a vaccine, and all of these methods have been utilised against COVID-19. The vaccine we have been working on is a recombinant vaccine, created by US biotech company, Novavax. This type of vaccine is produced using recombinant DNA technology and is aimed at enhancing the immune response to the virus and stimulating high levels of neutralising antibodies.
“First, researchers find out what is on the surface of the virus, such as a surface protein, and manufacture it so it can be used without the virus. It is then assembled in such a way that when injected, the body gives the right type of immune response. The end goal is to provide an individual with immunity and protect them from infection when exposed to the virus,” said A/Prof Griffin.
The start of human trials is a critical milestone in the journey towards a coronavirus vaccine. Before a potential vaccine reaches this point, pre-clinical studies using tissue-culture or cell-culture systems and animal testing are undertaken to assess the safety of the candidate vaccine, and its ability to provoke an immune response[1]. The Novavax product has already shown to be safe and effective in animal testing and has therefore progressed to human trials.
“Phase 1 trials are the first in-human studies to take place during vaccine development. These Novavax trials are being conducted by Nucleus Network at our Brisbane and Melbourne clinics, and are being carried out on a relatively small number of people (around 100). The focus at this point is on safety, with an early indication of efficacy. At Phase 1 we are not looking at protection from the virus – this is done once we have progressed to the next stage of trials,” said Dr Griffin.
Following a successful Phase 1 trial, the potential vaccine is tested on a much larger group of individuals, usually with several hundred to a few thousand participants. The purpose of Phase 2 trials is to start to determine efficacy and to further evaluate safety.[2]
Phase 2 is still predominantly focused on safety but is also starting to see if the vaccine actually works. If these results are supportive of moving forward, then we move to Phase 3 where the vaccine is administered to really large numbers of people
“At this stage, we want to see that people who have had the vaccine get much less of the infection than those people that haven’t. These studies are also used to monitor adverse effects and to collect information that will allow the vaccine to be used safely.
“There has been a lot of talk about how quickly vaccine research has progressed, whether we have skipped any steps, or if this has created any safety concerns. However, in many ways, we have actually been more thorough due to the level of scrutiny on these products. We have been able to do a lot of things sequentially and in parallel, meaning we have been progress a lot more quickly than usual,” said Dr Griffin.
Nucleus Network is the only multi-site Phase 1 clinical trials provider located in Australia and the USA. Nucleus Network provides high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia.
A/Prof Paul Griffin is a Fellow of the RCPA in Microbiology; Principal Investigator and Medical Director of Nucleus Network, Queensland; Principal Investigator on in excess of 120 clinical trials mostly early phase vaccine studies; and Director of Infectious Diseases and Conjoint Associate Professor Mater and the University of Queensland.
