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Brisbane-based needle-free vaccine patch pioneer Vaxxas has today announced the initiation of a Phase I clinical trial of its technology that is aiming to inoculate against COVID-19.
The clinical study of its proprietary high-density microarray patch (HD-MAP) technology will be conducted at the University of Sunshine Coast’s Sippy Downs clinical research location, and marks a major milestone for the research firm.
Upon successful completion of the clinical study and subsequent Phase II and III studies, Vaxxas will seek Therapeutic Goods Administration (TGA) and US Food and Drugs Administration (FDA) approvals to make the vaccine patch available as early as 2025.
Established in 2011 by the University of Queensland’s commercialisation arm UniQuest, Vaxxas recently received positive results from a trial that tested the patch on mice, finding that the HD-MAP could neutralise all of the variants of the COVID-19 virus tested by researchers.
The animal trials, led by UQ’s Dr Christopher McMillan and Dr David Muller, revealed that the patch was considerably more effective in neutralising COVID-19 variants than traditional needle vaccination delivery.
According to Vaxxas CEO David L. Hoey, the initiation of the Phase I trial is a major step forward for the biotech.
“Attaining this clinical milestone and building upon compelling preclinical data, we are excited by the rapid progress of our needle-free COVID-19 vaccine candidate,” Hoey said.
“Vaxxas’ HD-MAP technology can potentially enable cost-effective distribution without the need for extensive refrigeration, and our vaccination patch offers the potential for self-administration.
“This may enable an accelerated response in a pandemic situation and broader population coverage.”
This upcoming trial will assess the safety, tolerability and immunogenicity of the COVID-19 vaccine candidate in 44 healthy adults, aged 18 to 50 years inclusive, who have had three doses of an authorised COVID-19 vaccine with the last dose received at least four months prior to participating in the study.
In addition to assessing the safety of the vaccine, the trial will gather signals related to antibody and T-cell responses to dosing with the patch-delivered vaccine candidate.
“We are pleased to see our COVID-19 patch transition from the lab to Vaxxas for Phase I clinical trials,” Dr David Muller from The University of Queensland said.
“Our work demonstrated that the COVID-19 vaccine patch, when tested in mice, produces potent immune responses against every SARS-CoV-2 variant we tested, including delta and omicron in preclinical models.
“If these results translate to humans, this patch could be a great tool in the fight against COVID-19.”
Hoey added that the Trial’s priority was to determine the safety of the COVID-19 vaccine patch in humans.
“It is important to note that this is our first-in-human trial of the COVID-19 vaccine patch. We are starting at a very low dose with no adjuvants which we know are used regularly with vaccines to stimulate a greater immune response,” Hoey said.
“As such, the primary endpoint is safety. If the vaccine proves safe, we have a lot of flexibility to increase the dose or supplement the vaccine with an industry-standard adjuvant or even mRNA delivery on the patch in future trials if we need or wish to drive an even greater immune response than what we see in the Phase I trial.”
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