The trial will assess an avian flu vaccine delivered with Vaxxas’ proprietary needle-free vaccine patch, called the high-density microarray patch or HD-MAP.

Comprising 258 participants aged between 18 and 50 years old from  Queensland and Victoria, this trial represents Vaxxas’ largest Phase I clinical study to date.

Since its establishment in 2011, the biotech company has grown from a startup of four, to a business of over 150, opening a global headquarters and manufacturing site, the Vaxxas Biomedical Facility, in Brisbane in 2023. 

The Vaxxas high-density microarray patch (HD-MAP) consists of thousands of microscopic projections moulded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. The vaccine is delivered by simply applying a small patch briefly to the skin. 

Vaxxas is hopeful that this technology could minimise the costs and complexities of traditional vaccination delivery. HD-MAPs are easy to use, opening the floor for potential self-administration and have been shown to be more stable at higher temperatures which could simplify mass distribution by reducing the need for cold-chain storage. 

“Global pandemic threats require the world’s health organisations to have better and more accessible vaccine delivery options,” said CEO of Vaxxs, 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.” 

Vaxxas has previously successfully trialled its HD-MAP technology in delivering numerous vaccines including measles and rubella, influenza and COVID-19.

The upcoming trial will compare the response of participants to pre-pandemic avian influenza strain H7N9, when dosed with Vaxxas’ HD-MAP and conventional needle and syringe. Though avian flu in humans are mild, H7N9 has an observed Infection Fatality Rate of 39% and The World Health Organisation (WHO) states the strain is “of concern” and represents a potential serious pandemic threat to livestock and humans.

Vaxxas was awarded a $43 million contract by the US Government’s Biomedical Advanced Research and Development Authority to conduct the trial in response to potential future pandemic threats to public health.Other Vaxxas partners include the World Health Organisation (WHO), Gates Foundation, CEPI, Wellcome Trust and Queensland and Australian Governments.

Initial results from the trial are expected in 2025. Vaxxas projects its Brisbane-based Vaxxas Biomedical Facility will produce the first globally available vaccine patches in three to five years.