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Needle-free vaccine company Vaxxas is being supported by a US Government contract worth US$28.5 million ($43 million) to conduct a bird flu vaccine trial in Queensland and Victoria in the largest Phase 1 clinical study to date for the Brisbane-based biotech.
The US Government’s Biomedical Advanced Research and Development Authority (BARDA) is conducting the trial in response to potential future pandemic threats to public health and it comes on the heels of an outbreak of avian flu earlier this year that affected egg production in regional Victoria.
The clinical study will assess an avian flu vaccine delivered with Vaxxas’ proprietary needle-free vaccine patch technology, known as the high-density microarray patch (HD-MAP).
The technology delivers vaccines by applying a small patch briefly to the skin, which the company says potentially minimises the costs and complexities of traditional vaccination delivery.
The HD-MAP has been shown in early studies to be easy to use, with the potential for vaccines to be stable at room temperature, minimising the need for cold-chain refrigeration and facilitating distribution of vaccine patches by mail and courier for potential self-administration.
The proposed clinical study will include 258 healthy participants aged between 18 and 50, which Vaxxas says is the largest Phase I trial it has conducted so far using its HD-MAP technology.
"Global pandemic threats require the world’s health organisations to have better and more accessible vaccine delivery options,” says Vaxxas CEO David Hoey.
“With potential benefits such as thermostability, ease of use, and patient acceptability, Vaxxas’ HD-MAP is designed to be rapidly and broadly deployed to accelerate vaccination uptake and rates.”
While the influenza A virus has numerous strains that circulate globally, the World Health Organisation says the H7N9 avian influenza strain is “of concern” as most patients become severely ill.
The Vaxxas clinical study is being conducted at three of the University of the Sunshine Coast’s clinical trial centres in Queensland and the Doherty Clinical Trial centre in Melbourne.
The trial will compare the safety and immune response of participants to the pre-pandemic avian influenza strain H7N9, when dosed with Vaxxas’ novel HD-MAP as well as through conventional needle and syringe. Initial results from the trial are expected in 2025.
Founded in 2011, Vaxxas has been pursuing the commercial applications of technology developed at the University of Queensland to make vaccines more convenient courtesy of the HD-MAP technology.
The patch is covered in thousands of tiny vaccine-coated microprojections that deliver the vaccine to abundant immune cells naturally present just below the skin's surface.
Vaxxas last year opened a 5,500sqm headquarters at Hamilton in Brisbane’s inner east to scale up manufacturing of its needle-free vaccine patch platform. The facility is expected to produce the first globally available vaccine patches in three to five years.
In recent years, Vaxxas has successfully trialled HD-MAP in the delivery of various vaccines for conditions such as measles and rubella, influenza and COVID-19.
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