Vaxxas initiates clinical trial of its COVID-19 vaccine patch

Australian biotech Vaxxas, which is developing patch dispensers for different diseases, announced earlier this month it has initiated a “Phase I clinical trial with the first needle-free COVID-19 vaccine candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.”

Vaxxas said it will carry out the trial at the University of the Sunshine Coast’s Sippy Downs clinical research set-up and will involve 44 healthy Australians aged 18 to 50, each of whom “has had three doses of an authorized COVID-19 vaccine” with the last dose at least four months prior to the study.

“We are excited by the rapid progress of our needle-free COVID-19 vaccine candidate,” said Vaxxas Chief Executive Officer David L. Hoey, adding that their HD-MAP technology “offers the potential for self-administration,” which may enable broader population coverage and “accelerated response in a pandemic situation.”

The trial will test the patch’s safety, tolerability, and immunogenicity and gather signals related to antibody and T-cell responses to dosing with the patch-delivered vaccine candidate, according to the press release. The company said it is now working to gain U.S. Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) approvals for its vaccine patch.

Vaxxas’ COVID-19 vaccine

The Brisbane-based clinical-stage biotechnology company “holds an exclusive license from The University of Texas at Austin to the HexaPro, SARS-CoV-2 spike subunit vaccine for vaccination using a patch,” the release said. Vaxxas’ COVID-19 vaccine patch is “based upon HD-MAP delivery of HexaPro, a second-generation version of the spike protein used in all major U.S. approved COVID-19 vaccines, which was modified to be more stable and immunogenic than its predecessor, giving potential coverage of all major SARS-CoV-2 variants.”

Its technology platform “utilizes an ultra-high-density array of projections—invisible to the naked human eye—applied to the skin as a patch” coated with the HexaPro vaccine and integrated into a single-use applicator, the release said. When applied to the skin, the patch is boosting immune response by delivering the vaccine to immune cells just under the skin. Due to its dry-coating technology, it remains stable and active without the need of maintaining the refrigerated “cold chain”.

According to an earlier announcement from Vaxxas, published in July, the “protein-based vaccine patch has proved effective against all major variants of COVID when given to mice.”

Other applications

Vaxxas also announced it has completed a “Phase one study of measles and rubella vaccine patch working with the Bill and Melinda Gates Foundation,” adding it would soon “announce a collaboration around a typhoid vaccine patch.”

The company said it was hosting five other clinical trials around specific vaccines, including for the “pandemic influenza vaccine in a partnership with the U.S. government, a seasonal flu patch, and a program with pharmaceutical giant Merck.” BIO member Merck teamed up with Vaxxas in 2012 to research the drug-delivery patch and to evaluate the potential use of the Nanopatch platform for a Merck vaccine candidate, with the option to expand the alliance to up to two more vaccines.

Two years ago, Vaxxas announced that Merck “has exercised its option to utilize Vaxxas’ proprietary High-Density Microarray Patch (HD-MAP) platform for a vaccine candidate.”

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