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Clinical Trial Underway Testing Influenza Vaccine Patch

Nanopatch system

Vaccine patch system in use (Vaxxas Pty Ltd)

10 Feb. 2023. A clinical trial has begun testing a commercially-available flu vaccine administered with a painless patch device against conventional syringe injection delivery. The study is sponsored by Vaxxas Pty. Ltd. in Brisbane, Australia and Cambridge, Mass., developer of the vaccine patch delivery system, and conducted at clinics in Australia.

Vaxxas is creating high-density microarray patch or HD-MAP with tiny needles that deliver the same vaccines as given with conventional syringe injections, but in a lower dose. The patch has thousands of microscale needles, of about 0.25 millimeters, containing dried active vaccine ingredients. When placed on the skin, the needles penetrate outer skin layers to allow the vaccine to enter the blood stream, while the single-use device seals off the patch area to enable a sterile environment. The company says when the patch delivers a vaccine, the microneedle projections into the skin also trigger a fast immune response in recipients’ lymph nodes.

Vaxxas says HD-MAP vaccines can be shipped and stored in ambient temperatures for at least 12 months, thus not requiring refrigeration or freezing for transport or storage, called the cold-chain. And the lower dose allows health authorities to expand their vaccine stocks to larger population. The company says the device could make possible self-administration of vaccines, but clinical trials of the HD-MAP, including the new study, administer vaccines with trained clinicians. In Nov. 2022, Science & Enterprise reported on the start of one such trial in Australia testing the Vaxxas device delivering a Covid-19 vaccine.

“Vaccine delivered via a HD-MAP patch is easy to use and can potentially be self-administered,” says Vaxxas CEO David Hoey in a company statement released through BusinessWire. “It can simplify distribution by removing or reducing the need for refrigeration, and avoids needles.”

Looking mainly for safety and tolerability

Influenza continues to be a public health threat worldwide. World Health Organization estimates 3 to 5 million seasonal flu cases each year, leading to as many as 650,000 deaths. While cases can range from mild to severe, children under five years of age, pregnant women, and older individuals are at greatest risk of severe disease or complications. Centers for Disease Control and Prevention says on average about 8 percent of the U.S. population gets the flu each year.

The new clinical trial is assessing the HD-MAP device for delivery of the Influvac Tetra influenza vaccine, a commercially-available product in Australia designed to protect against four flu strains, and given by syringe injections into the arm. The study team is enrolling 150 healthy adult individuals in Australia randomly assigned to receive one of three dose levels of the vaccine with the patch, a patch with no vaccine on its needles, or a conventional Influvac Tetra syringe-delivered vaccine.

The study team is looking primarily for safety and tolerability of the HD-MAP, checking for skin reactions or other adverse effects from the device and conventional syringes, at four points up to 57 days after delivery. Immediately after HD-MAP administration, the team is also taking electron microscope images to check on skin-penetration performance of the device. In addition, the researchers are taking blood samples at three points to check for antibody concentrations, also up to 57 days after receiving the patch or injection.

Vaxxas says it plans to conduct a similar trial of an HD-MAP influenza vaccine in the U.S., under contract to the Biomedical Advanced Research and Development Authority, or BARDA, a U.S. federal agency.

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