Vaxxas has announced the initiation of a Phase I clinical trial evaluating a vaccine against the pre-pandemic avian influenza strain H7N9, delivered via the company’s high-density microarray patch (HD-MAP) technology. The multi-center trial, conducted in collaboration with clinical sites in Australia, is supported by the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
The trial aims to assess the safety and tolerability of the monovalent H7N9 vaccine when administered intradermally using Vaxxas’ HD-MAP. This innovative delivery system involves applying a small patch to the skin, potentially offering a less invasive and more convenient alternative to traditional needle and syringe vaccinations. The study is enrolling 258 healthy participants aged 18 to 50 years.
HD-MAP Technology for Enhanced Vaccine Delivery
Vaxxas' HD-MAP platform delivers vaccines directly to the dense populations of immune cells residing in the skin. This targeted delivery is designed to enhance immune responses and potentially reduce the required vaccine dose. The HD-MAP technology also offers the advantage of thermostability, allowing vaccines to remain stable at room temperature, which could significantly simplify distribution and eliminate the need for cold-chain refrigeration.
According to Vaxxas, market research indicates a significant preference for HD-MAP vaccination over conventional needle-and-syringe methods, highlighting the potential for improved patient acceptability and increased vaccination rates.
Trial Design and Endpoints
The Phase I trial will compare the safety and immune response of participants receiving the H7N9 vaccine via HD-MAP with those receiving it through traditional needle and syringe administration. The primary endpoints include safety and tolerability, while secondary endpoints will assess the immunogenicity of the vaccine, measuring antibody responses and other relevant immune parameters. Initial results from the trial are anticipated in 2025.
Addressing a Potential Pandemic Threat
Avian influenza strains, including H7N9, pose a significant pandemic threat to both livestock and humans. The World Health Organization (WHO) has identified H7N9 as a strain of concern, noting that many infected patients have become severely ill. Since early 2013, over 1,500 human infections with H7N9 have been reported globally, with an observed infection fatality rate of 39%, according to the WHO.
David L. Hoey, President and CEO of Vaxxas, emphasized the importance of accessible vaccine delivery options in addressing global pandemic threats. "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," Hoey stated.
Prior Clinical Experience with HD-MAP
Vaxxas' HD-MAP technology has been evaluated in multiple clinical trials involving over 500 participants, demonstrating a favorable safety profile and the ability to elicit robust immune responses. The company recently reported positive results from a Phase I trial of a measles and rubella (MR) vaccine delivered via HD-MAP.
