Vaxxas Initiates Phase I Clinical Study of First Needle-Free, Inactivated Seasonal Influenza Vaccine

Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced the initiation of a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.

The vaccine being delivered by HD-MAPs is a commercially available IIV4. The specific strains of influenza virus targeted in any given seasonal IIV4 are established annually by regulatory health agencies and encompass two strains of influenza A and two strains of influenza B. By targeting four significant strains of the influenza virus, quadrivalent influenza vaccines are designed to offer broad immune coverage against the flu viruses expected to circulate across the globe for a given flu season.

A common infectious disease, influenza is responsible for three to five million severe cases worldwide annually, along with up to 650,000 deaths per year. Researchers estimate that fear of needles affects up to 25 percent of adults, and may lead to 16 percent of people in developed world countries, such as the US and Australia, skipping routine and pandemic vaccinations.

Vaxxas Chief Executive Officer David L. Hoey said, “Vaccine delivered via a HD-MAP patch is easy to use and can potentially be self-administered; it can simplify distribution by removing or reducing the need for refrigeration; and avoids needles. All factors that could improve access to, and acceptability of, current influenza vaccines, offering greater protection each season to communities around the globe. We are excited by the potential of our needle-free, seasonal flu patch development program. This clinical trial builds upon our compelling body of data from clinical and preclinical studies using flu vaccines.”

In contrast to current influenza vaccines given by needle and syringe which must be stored under refrigerated conditions, typically 2°C – 8°C to remain effective, Vaxxas has shown that influenza vaccine on the HD-MAP can be kept at temperatures up to 40°C, for at least 12 months, without losing effectiveness. These thermostability benefits of a HD-MAP influenza vaccine have the potential to enable broader distribution, at a lower cost.

The Phase I clinical trial will assess the safety, tolerability, and immunogenicity of the inactivated influenza vaccine quadrivalent (IIV4) candidate in approximately 150 healthy participants, aged 18 – 50 years inclusive, who have not received an influenza vaccine within the last six months and have received no vaccines of any kind for at least thirty days prior to participating in the study. In addition to this seasonal IIV4/HD-MAP Phase I clinical trial, Vaxxas is preparing for clinical evaluation of pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA). In 2022, the company also initiated a Phase I clinical study of the first COVID-19 vaccine candidate delivered using its HD-MAP technology.