BARDA Funding Vaccine Patch Clinical Trial

Vaccine patch system in use (Vaxxas Pty Ltd)

5 Oct. 2020. The U.S. government’s medical preparedness agency is funding a clinical trial of a patch that dispenses vaccines with a much lower dose than syringes. The Biomedical Advanced Research and Development Authority, or BARDA, awarded a $22 million contract to Vaxxas — in Cambridge, Massachusetts and Brisbane, Australia — for an early-stage study of the vaccine patch.

The Vaxxas high density microarray patch, or HD-MAP, is a polymer wafer about nine millimeters square. The device, with some 3,100 microscale needles, is applied to the arm for a few seconds. The patch is designed for ease of use, as well as to overcome fear and pain of injections, and can also be stored and shipped without refrigeration, a limiting requirement for conventional vaccines.

A March 2020 PLoS Medicine journal article reports on an early-stage clinical trial testing the HD-MAP patch for safety and ability to generate an immune response with an H1N1 influenza A antigen. The trial tested the device in Australia delivering H1N1 antigens in healthy adults against the standard intramuscular-injected four-strain influenza vaccine, a standard injection with the same amount of H1N1 antigens as in the patch, and an empty microarray patch.

The researchers found the lowest dose of 2.5 micrograms of antigen on an HD-MAP patch generated about the same level of antibody concentrations in participants as the full vaccine dose delivered by a standard syringe injection with six times the antigen. Also, the full dose of influenza vaccine on the HD-MAP patch produced faster and higher antibody concentrations compared to standard influenza injections. And the antigens on HD-MAP patches remained stable, even when stored for 12 months in temperatures of 40 degrees C, or 104 F.

The $22 million BARDA contract funds another early-stage trial of the HD-MAP patch. In this study, some 400 participants will be randomly assigned to received an influenza vaccine either with or without an adjuvant or booster. The study team is looking primarily for an adverse reactions from the HD-MAP, as well as immune responses generated by vaccines dispensed with the device. Vaxxas is contributing another $2.1 million for the trial.

“We are excited to partner with BARDA to rapidly deploy Vaxxas’ HD-MAP technology,” says Vaxxas CEO David Hoey in a company statement released through BusinessWire, “which holds the promise of significantly improving pandemic response with needle-free vaccine delivery that is more effective and readily accepted.”

The company believes its HD-MAP device can also help respond to pandemics, such as Covid-19. The device delivers lower doses of vaccines, enabling available supplies to reach more people. And its ability to keep vaccines chemically stable at ambient temperatures makes it possible to use conventional logistics services rather than needing refrigeration at each storage and delivery stage.

As reported by Science & Enterprise in May, Vaxxas is licensing its HD-MAP technology to drug maker Merck for an undisclosed vaccine candidate. The company says it is also building a manufacturing system for its devices that will be able to deliver more than 250 million vaccine doses per year.

More from Science & Enterprise:

• Patch Delivers Low-Dose Vaccine with Full-Dose Power
• Skin Patch Senses Glucose, Emits Insulin as Needed
• Patch Device Stores Vaccine Record in Skin
• Peanut Allergy Patch Under FDA Review
• Microneedle Patch Monitors Antibiotic Levels

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