Brisbane-based needle-free vaccine maker Vaxxas has today announced the launch of a Phase I clinical trial for a seasonal flu inoculation, delivered via its high-density microarray patch (HD-MAP) technology.
Announced three weeks after the company secured $6.4 million from the Coalition for Epidemic Preparedness Innovations (CEPI), Vaxxas will assess the safety, tolerability and immunogenicity of a seasonal influenza vaccine quadrivalent (IIV4) in approximately 150 healthy participants.
Test subjects will be 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 30 days prior to participating in the study.
Conducted via the University of Sunshine Coast’s clinical research locations in Brisbane, Morayfield and Sippy Downs, the study will assess whether a seasonal influenza vaccine quadrivalent (IIV4) candidate can be safely delivered by Vaxxas’ HD-MAP medical device.
Being a quadrivalent influenza vaccine, the inoculation is designed to offer broad immune coverage against multiple flu viruses expected to circulate across the globe for a given flu season.
Vaxxas CEO David Hoey says administration of the quadrivalent vaccine via the company’s needle-free platform has the potential to increase vaccination coverage and uptake.
“Vaccine delivered via HAP-MAP patch technology removes the need for needle and syringe, is easy to use, and can potentially be self-administered,” says Hoey.
“It also has the potential to simplify distribution by removing or reducing the need for refrigeration.”
Vaxxas has shown in clinical trials that its HD-MAP can be kept at temperatures of up to 40 degrees Celsius for at least 12 months without losing effectiveness, enabling potentially broader distribution at a lower cost.
“The potential benefits of Vaxxas’ needle-free vaccine platform, supported by clinical trials, are all factors that could improve access to, and acceptability of, current influenza vaccines,” says Hoey.
“This will offer greater protection each season to communities in Australia, and around the globe.”
Further, development of the HD-MAP will be great news for those with a fear of needles; a phobia that affects up to 25 per cent of adults according to the US Centres for Disease Control and Prevention (CDC).
Further research has demonstrated that trypanophobia (the intense fear of needles) may lead to 16 per cent of people in developed countries, including Australia and the US, skipping routine and pandemic vaccinations.
“We are excited by the potential of our needle-free, seasonal flu patch development program,” Hoey added.
“This clinical trial build upon our compelling body of data and preclinical studies using flu vaccines.”
Beyond the clinical trial for the flu vaccine, Vaxxas is preparing for clinical evaluation of a pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA).
The Brisbane-based medtech closed a $34 million financing round in December last year, with the funds to facilitate the expansion of its manufacturing capabilities towards a commercial scale and advance the ongoing clinical trials of its needle-free vaccine tech.
That added to an $8 million Federal Government grant received by Vaxxas in September and came just a month after the company commenced clinical trials of its proprietary high-density microarray patch (HD-MAP) at the University of Sunshine Coast’s Sippy Downs clinical research labs.
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