Vaxxas announced that it began a multi-center Phase I clinical trial of a vaccine against avian flu using its high-density microarray patch.
The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to the skin as a patch, the system rapidly delivers vaccines to immune cells below the skin surface.
HD-MAP offers improved thermostability, potentially reducing the cost and complexity of cold-chain distribution and storage. It also potentially requires less training to administer and could even lead to self-administration.
The new trial, led by Vaxxas in collaboration with Australian clinical sites, evaluates a vaccine against pre-pandemic avian influenza strain H7N9. HHS’ Biomedical Advanced Research and Development Authority (BARDA) unit provides oversight for the trial. It aims to expand foundational novel countermeasure capabilities in response to potential future pandemic threats to public health.
Vaxxas says its trial includes 258 healthy participants between 18-50 years old. It marks the largest Phase I trial conducted to date by the company with its HD-MAP technology. The company plans to compare the safety and immune response of participants to this H7N9 vaccine, when dosed with Vaxxas’ novel HD-MAP as well as through conventional needle and syringe. It expects initial results in 2025.
“Global pandemic threats require the world’s health organizations 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,” David L. Hoey, President and CEO of Vaxxas, said. “Market research indicates that – given the choice – vaccination by HD-MAP is significantly preferred over conventional needle-and-syringe.”