Vaxxas Begins Phase I Trial of H7N9 Vaccine Using HD-MAP

Vaxxas, a biotechnology company based in Cambridge, MA, USA, and Brisbane, Australia, has launched a Phase I clinical trial for a vaccine aimed at the pre-pandemic avian influenza strain H7N9. This trial employs Vaxxas' innovative high-density microarray patch (HD-MAP) technology and is conducted in collaboration with several Australian clinical sites. The trial is overseen by the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services.

The HD-MAP platform by Vaxxas represents a novel approach to vaccine delivery. It involves applying a small patch to the skin, which simplifies the vaccination process by eliminating the need for needles and syringes. This method can enhance immune responses by targeting dense populations of skin-resident immune cells and may also offer dose-sparing benefits. Additionally, the HD-MAP can maintain vaccine stability at room temperatures, thereby reducing the need for cold-chain logistics and facilitating easier distribution.

The clinical study encompasses 258 healthy participants aged between 18 and 50 years, marking the largest Phase I trial for Vaxxas' HD-MAP technology so far. The trial aims to compare the safety and immune responses of participants receiving the H7N9 vaccine via the HD-MAP against those vaccinated using conventional needle and syringe methods. Preliminary results are anticipated in 2025 and will be reviewed by BARDA and published by Vaxxas and its collaborators.

David L. Hoey, Vaxxas' President and CEO, emphasized the importance of accessible vaccination solutions in the face of global pandemic threats. He highlighted that the HD-MAP's features such as thermostability, ease of use, and patient acceptability could significantly boost vaccination rates. Market research indicates a strong preference for the HD-MAP over traditional needle-and-syringe vaccination methods.

The H7N9 influenza A virus is a significant concern according to the World Health Organization (WHO), as it has caused severe illness in most affected individuals. In response, this Phase I study is being conducted at University of the Sunshine Coast’s clinical trial centers in Queensland and the Doherty Clinical Trial center in Melbourne, Victoria.

The H7N9 strain of avian influenza has posed a significant health risk since its detection, affecting birds, livestock, and humans. The World Health Organization has labeled this strain as concerning due to its high infection fatality rate, which stands at 39%. Since early 2013, more than 1,500 cases of H7N9 infection have been reported worldwide.

Vaxxas' HD-MAP technology consists of thousands of microscopic projections on a patch, each embedded with a small dose of dried vaccine. When the patch is applied to the skin, it delivers the vaccine to immune cells located just beneath the skin's surface. This method offers several advantages over traditional liquid vaccines, including stability at higher temperatures and ease of administration.

To date, Vaxxas' HD-MAPs have been tested in hundreds of trial participants and have shown to elicit immune responses comparable to or greater than those produced by traditional injected vaccines at lower doses. The HD-MAP system's ease of use and potential for self-administration could revolutionize vaccine distribution, especially during pandemics, by allowing vaccines to be delivered directly to homes, workplaces, and schools, thus reducing the need for individuals to gather in central locations for vaccination.

In summary, Vaxxas is making significant strides in vaccine delivery with its HD-MAP technology, which promises to enhance the efficiency and reach of immunization programs worldwide.