Australian company Vaxxas has launched a phase one clinical trial of a needle-free COVID-19 vaccine candidate.
The vaccine is being developed based on the company's high-density microarray patch (HD-MAP) technology.
The trial is being conducted at the University of the Sunshine Coast’s Sippy Downs clinical research location.
It will assess the safety, tolerability, and immunogenicity of the candidate in 44 healthy adults, aged 18 to 50, 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.
The trial is also designed to gather signals related to antibody and T-cell responses to dosing with the patch-delivered vaccine candidate.
The company said that upon the successful completion of the phase one trial, and subsequent later-stage studies, the COVID-19 vaccine patch could be available as early as 2025.
The COVID-19 vaccine patch is based upon HD-MAP delivery of a SARS-CoV-2 spike subunit vaccine candidate from The University of Texas at Austin (UTA).
The vaccine candidate is a second-generation version of the spike protein used in the major US-approved COVID-19 vaccines. It has been modified for stability and immunogenic response, giving potential coverage of all known SARS-CoV-2 variants.
"Results from preclinical animal studies completed in July of this year support the potential efficacy of the COVID-19 vaccine patch against all current variants of concern," said the company.
“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,” said Vaxxas CEO David Hoey.
“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.”
“At a time when the world is facing more emerging variants of the COVID-19 virus, it’s especially important to continue to build out our arsenal of tools to prevent infection and serious disease,” said Jason McLellan, a professor of molecular biosciences and Welch Chair in Chemistry at The University of Texas at Austin.
“Clinical testing of this patch-based vaccine that uses UTA’s vaccine candidate represents a significant step towards equipping the globe for new phases of the fight against COVID-19.”
“We are pleased to see our COVID-19 patch transition from the lab to Vaxxas for Phase I clinical trials,” said Dr David Muller from The University of Queensland.
“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,” he added.
“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,” continued Mr Hoey.
“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.”