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Vaccine Patch Shown Safe, Induces Immune Response

Nanopatch system

Vaccine patch system in use (Vaxxas Pty Ltd)

6 June 2023. Initial results from a clinical trial show a patch device delivering a Covid-19 vaccine is well tolerated by recipients and triggers a measurable immune response. Results of the trial were presented yesterday at the Biotechnology Innovation Organization or BIO annual meeting in Boston, by the vaccine technology company Vaxxas Pty. that developed the device.

Vaxxas — in Cambridge, Mass. and Brisbane, Australia — is creating an alternative method to conventional syringes for delivering vaccines, a single-use patch applied to the skin the company calls a high-density microarray patch, or HD-MAP. The plastic HD-MAP patch contains some 1,700 tiny projections, about 0.25 millimeters in length, with a vaccine coated on the tips. Vaxxas says the patch’s projections penetrate only the skin’s outer layer, enough to trigger a reaction from the immune system but without causing pain. That initial immune reaction, says the company, carries the vaccine from HD-MAP to the lymph nodes, where it induces a more general immune response. The vaccine-laden patch is delivered in a spring-fed single-use cylinder, pressed and held on the skin for two minutes.

In this case, the vaccine is HexaPro, designed to protect against the SARS-CoV-2 virus responsible Covid-19 infections and disease. Unlike most conventional Covid-19 vaccines, including those made with messenger RNA, HexaPro is made with a synthetic protein formulated to remain bioactive in ambient conditions, thus not needing constant refrigeration from production through administration. HexaPro is a product of molecular biology and engineering labs at University of Texas in Austin, licensed to Vaxxas.

Eight-fold higher antibody levels

The early-stage clinical trial enrolled 44 healthy adults at a clinic in Australia, age 18 to 50, already vaccinated against Covid-19. Participants received three applications of the device, randomly assigned for a partial or full dose or a placebo. Participants were assessed for SARS-CoV-2 antibody levels before the trial, then tracked at periodic intervals for 90 days. The study team is looking for mainly for any adverse reactions to the patch and vaccine, including skin irritations and swelling at the application site, as well as more serious adverse effects. The team is also measuring antibody concentrations in blood and saliva samples during that 90-day period. Science & Enterprise reported on the start of the trial in Nov. 2022.

At the BIO meeting, Vaxxas reported on the study’s findings after 28 days. The company says the HD-MAP patches are well tolerated by recipients with no serious adverse effects. In addition, an analysis of blood and saliva samples show vaccine recipients with an eight-fold higher concentration of relevant antibodies, on average, and also a greater antibody response among those receiving the higher vaccine dose.

“We believe,” says Vaxxas CEO David Hoey in company statement released through BusinessWire, “our patch-based delivery of a next generation spike protein has the potential to offer best-in-class protection against Covid-19 along with cost-effective distribution without the need for extensive refrigeration.”

In clinical studies so far, HD-MAP vaccines are administered by clinicians to provide for consistent conditions. However, as reported by Science & Enterprise in Mar. 2023, Vaxxas is also assessing the feasibility of self-administration by patients, with findings from a clinical trial showing vaccines applied by participants to their own arms with the device works as well in the skin as when administered by clinicians.

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