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Covid vaccine delivered using Vaxxas patch goes into clinical trials

Manufacturing News

Vaxxas, a Brisbane-based company attempting to replace the needle and syringe for vaccine deliveries, has announced the first in-human trials for a Covid-19 vaccine candidate using its delivery platform.

In a statement on Wednesday, the medtech company said a Phase I clinical study had been initiated, conducted at the University of the Sunshine Coast’s Sippy Downs clinical research site.

The study will use a a second-generation SARS-CoV-2 spike protein vaccine developed by The University of Texas at Austin, coated on Vaxxas’s HD-MAP (high-density microarray patch) devices. It will be administered as a fourth vaccine dose to a group of 44 healthy adults aged 18 – 50 years.

“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,” said Vaxxas CEO David L. Hoey.

Previous tests include the Covid-19 candidate – named Hexapro – administered to animals, with results announced in June last year, and demonstrating “significantly enhanced T-cell and spike-specific antibody responses” versus needle-and-syringe delivery.

“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 Hoey.

The CEO added that Vaxxas’s technology could potentially offer cost-effective distribution, as it does not require extensive refrigeration and could be self-administered. 

The company estimates that the Hexapro-and-patch combination could be available as soon as 2025.

Last month Vaxxas said it had successfully automated the process it uses to make its patches in collaboration with AIM Lab, necessary to progress to quantities required for later-phase trials.

Vaxxas was established in 2011 to commercialise its HD-MAP platform, formerly known as “Nanopatch.” This is a needle micro-array concept used to painlessly administer dry vaccines, developed by Professor Mark Kendall and his team. 

It operates out of Brisbane’s Translational Research Institute.

Picture credit: Vaxxas

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