Vaxxas’ high-density microarray patch technology uses an array of microprojections – invisible to the naked human eye – to deliver the vaccine to the skin via a small patch sitting inside a small applicator device. Source: Vaxxas/Business Wire.

Vaxxas has commenced a Phase I clinical trial for a pre-pandemic avian influenza A virus (H7N9) vaccine, leveraging a high-density microarray patch (HD-MAP) for delivery.

Vaxxas’ HD-MAP platform, which administers vaccines via a patch applied to the skin, eliminates the challenges linked to traditional needle-based methods.

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Using an array of microprojections not visible to the naked human eye, the platform targets immune cells in the skin, potentially improving immune responses and reducing vaccine doses.

The HD-MAP’s ease of use and stability at room temperature could simplify distribution, allowing vaccines to be sent directly to recipients for self-administration.

The study, a collaboration with Australian clinical sites, is overseen by the Biomedical Advanced Research and Development Authority (BARDA), under the US Department of Health and Human Services.

Led by the company, the multicentre trial will enrol 258 healthy subjects aged between 18 and 50 years.

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It is designed to assess the vaccine’s safety and immune response, comparing the HD-MAP delivery to conventional injection methods.

The company anticipates reporting the initial data from the trial next year.

Vaxxas president and CEO David Hoey said: “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.

“Market research indicates that, given the choice, vaccination by HD-MAP is significantly preferred over conventional needle-and-syringe.”

In November last year, the company reported positive results from a Phase I clinical trial for the measles and rubella (MR) vaccine delivered using HD-MAP.