Covid-19 Vaccine Patch Clinical Trial Begins

High density microarray patch (Vaxxas, Univ. of Queensland)

8 Nov. 2022. Developers of a patch with tiny needles instead of a syringe to deliver vaccines say a clinical trial testing a Covid-19 patch is now underway in Australia. Vaxxas, based in Cambridge, Massachusetts and Brisbane, Australia, says the trial is testing its high-density microarray patch, or HD-MAP, with a vaccine formulation licensed from University of Texas in Austin.

Vaxxas says its HD-MAP device meets a continuing need for easier and more practical methods to deliver vaccines than the traditional syringe. The company says each HD-MAP has microscale needles, about 0.25 mm in length, coated with a dried vaccine formulation. The patch is loaded into a self-contained spring-loaded applicator device for delivery into the forearm that individuals can administer themselves in two minutes, without a trained clinician. The company says the vaccine patch does not need extensive cold-chain techniques required to store and transport syringe-delivered vaccines.

For its Covid-19 patch, Vaxxas is using a vaccine formulation called HexaPro developed in labs at UT-Austin. As reported in Science & Enterprise in Mar. 2022, HexaPro is a synthetic protein product of molecular biologists and chemical engineers, designed for inexpensive production in eggs, like most influenza vaccines today. Plus, HexaPro has a longer shelf life than conventional vaccines and requires no special handling, such as deep freezing. Vaxxas licenses exclusive rights to HexaPro for delivery via a vaccine patch.

Safety and immune reactions tracked

“Vaxxas’ HD-MAP technology,” say Vaxxas CEO David Hoey in a company statement released through BusinessWire, “can 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.”

The early-stage clinical trial is enrolling 44 healthy adults, age 18 to 50, at a university clinic in Sippy Downs, Australia. Participants will already have three doses of Covid-19 vaccine, with the last dose at least four months earlier. Participants are randomly assigned to receive either a low or higher dose of HexaPro or a placebo through the patch. For the trial, a clinician is administering the patch, to ensure consistency.

Participants are then tracked for 28 days, with the study team looking primarily for adverse effects from the vaccine, although skin reactions at the delivery sites are also tracked for 90 days. The team is taking blood and saliva samples as well at the beginning of the trial, then at several points up to 90 days after receiving the vaccine to measure antibody and T-cell immune responses.

Hoey notes about the trial, “We are starting at very low dose with no adjuvants which we know are used regularly with vaccines to stimulate a greater immune response.” In addition, says Hoey, “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.”

More from Science & Enterprise:

• RSV Nose Drops Vaccine Gets FDA Fast Track Tag
• Nasal Spray Vaccines Get CEPI, NIH Funding
• Trial Shows Oral Covid-19 Vaccine Produces Antibodies
• CEPI Funds New Broad Coronavirus Vaccine
• AI Drug Company Creating Covid-19 Therapy for Rapid Delivery

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