The study will assess the safety, tolerability, and immunogenicity of the IIV4 candidate in around 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.
The vaccine being delivered by HD-MAPs is a commercially available IIV4.
Vaxxas said this clinical trial builds upon the company’s body of data from clinical and preclinical studies using flu vaccine.
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, explained Vaxxas.
The company’s high-density microarray patch (HD-MAP) technology platform utilizes an ultra-high-density array of projections – invisible to the naked human eye – applied to the skin as a patch sitting inside a small applicator device. When applied to the skin, the patch delivers vaccine to the abundant immune cells immediately below the skin surface. It maintains that this approach enhances the efficiency and effectiveness of resulting immune responses of vaccines.
Researchers estimate that fear of needles affects up to 25% of adults and may lead to 16% of people in developed world countries, such as the US and Australia, skipping routine and pandemic vaccinations.
Vaxxas’ core technology was initially developed at the University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization company UniQuest.
Last month the biotech announced that it has secured a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of its needle-free vaccine-patch delivery technology for mRNA vaccines.
The company also recently completed a financing round, announcing in December 2022 that it had raised US$23m (A$34m) in new funds, which would be directed at advancing multiple vaccine programs in the clinic and ramping up manufacturing capabilities towards commercial scale. Vaxxas has its development headquarters in Brisbane, Australia and its commercialization focus in the US in Cambridge, Massachusetts.
Ease of use
Vaxxas CEO, David L Hoey, spoke about the potential of the company’s needle-free, seasonal flu patch development program, saying a 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.”
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 said it 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, it added.
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 US 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.