I am preparing clinical trials for two vaccines we have been developing — for malaria and rheumatic fever.
This is an important area of medical research. While Australia is not a malaria country, malaria is a major world health problem. The World Health Organization has estimated that malaria causes over 200 million cases of fever every year. In 2010, around 655 000 people died from the disease, most of whom were children under the age of five. Most deaths occur among children in Africa where a child dies every minute from malaria. There is a high rate of incidence of rheumatic fever in Indigenous Australians, which can cause long-term health problems.
The vaccines have been a long time coming. I have worked in this research area for over 30 years, and the rheumatic fever vaccine has been in development for 10 years and the malaria vaccine for two years. While I have worked on other researcher’s trials and raised money for trials in the past, this will be the first clinical trial that I have led.
These trials will be a Phase 1 ‘first in human’ studies, which means that this is the first time we will be testing them in humans.
Our clinical trial volunteers come from all sectors and all walks of life. We offer a small amount of money for expenses and inconvenience. This does attract some volunteers. But for the most part people get involved because they want to be part of a project that will make a difference.
When I first talk to clinical trial volunteers I discuss what we are doing, why we are doing it, and the risks. It is important that the volunteers are fully educated about the trial. I think most people find this interesting and it is also one of the reasons they are involved in trials. They are interested in what we are doing and why we are doing it, and the science behind the research.
The doctors that become involved in the trials at the hospitals also benefit from the added understanding of the disease and the science that they gain through being involved.
The Phase 1 trial will take between three and six months, and then we will analyse the data we have collected. The main things we will be looking for is safety — are there any side effects we need to know about, and effectiveness — do the vaccines stimulate the immune system to protect against disease.
If the vaccines ‘pass the test’, in other words if they are found to be safe and effective, then we will move on to other trials involving more volunteers over a longer period. We can conduct some further trials here in Australia and I have also been working with colleagues in Africa to organise trials in Uganda and Ghana.