Vaxxas has initiated a multi-centre Phase 1 clinical trial of a vaccine against pre-pandemic avian influenza strain H7N9, using its high-density microarray patch (HD-MAP).
Vaxxas leads the multi-centre trial with oversight by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services. It is designed to expand foundational novel countermeasure capabilities in response to potential future pandemic threats to public health.
Vaxxas' HD-MAP platform delivers vaccines by briefly applying a small patch to the skin, potentially minimising the costs and complexities of traditional vaccination delivery.
The HD-MAP aims to deliver vaccine directly to the dense populations of skin-resident immune cells, enhancing immune responses with potential dose-sparing benefits.
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, avoiding or minimising the need for cold-chain refrigeration and facilitating distribution of vaccine patches by mail and courier for potential self-administration.
The clinical study includes 258 healthy participants between the ages of 18 and 50, making it Vaxxas's largest Phase 1 trial conducted with its HD-MAP technology to date.
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. Vaxxas and its clinical collaborators will provide BARDA with the trial's initial results and publish them.
"Global pandemic threats require the world's health organisations to have better and more accessible vaccine delivery options. 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," said David Hoey, CEO of Vaxxas.
The influenza A virus circulates as numerous strains across the globe. The World Health Organization states the H7N9 avian influenza strain is "of concern" as most patients become severely.
This Australian-based Phase 1 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, Victoria.
