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Vaccine Patch Shown Safe, Produces Measles/Rubella Antibodies

High-density micro-array patch applied to the upper arm

High-density micro-array patch applied to the upper arm (Vaxxas)

27 Nov. 2023. A vaccine delivered with a patch device is shown in a clinical trial to generate neutralizing antibodies against measles and rubella similar to conventional injections. Results of the trial, conducted among healthy adult volunteers in Australia and reported on 17 Nov. 2023 in the journal MDPI Vaccines, also show the patch-delivered vaccine is safe and well tolerated.

Measles is a highly contagious viral disease causing skin rash, coughing, and sneezing, but largely controlled in some parts of the world through widespread childhood vaccination. Where vaccinations are not readily available, often in lower-resource regions, measles is still a threat to children, and according to the the Measles and Rubella Partnership, claimed 128,000 lives in 2021. Rubella, sometimes called German measles, is a milder form of the disease, but can lead to birth defects among pregnant women, including children with congenital rubella syndrome, a disease causing multiple birth defects.

Vaxxas, a biotechnology company in Cambridge, Mass. and Brisbane, Australia, is developing a patch-applicator device as an alternative delivery vehicle for vaccines. The Vaxxas device uses high-density microscale needles on a small patch, with the needles about 0.25 millimeters in length that do not cause pain, delivered in a single-use spring-loaded applicator. The company says the needles are coated with the vaccine and penetrate to only the outer skin layers, enough to alert the immune system that carries the vaccine to lymph nodes for invoking a general immune response. And Vaxxas says vaccines on the patch can be stored at ambient temperatures without refrigeration.

Science & Enterprise reported on clinical trials of the Vaxxas patch with a Covid-19 vaccine, showing the vaccine delivered with the device is well-tolerated and generates an immune response similar to conventional injections. The company is also testing the patch with a commercial influenza vaccine, and developing another device to deliver a typhoid vaccine. Results from a separate trial support the feasibility of individuals self-administering vaccines with a micro-needle patch, without the supervision of a clinician.

Comparable antibody production rates as injections

In the new early-stage trial, Vaxxas enrolled 63 healthy adult volunteers in Australia to test the patch device with a vaccine against measles and rubella. Participants were randomly assigned to received a patch with either a high or low dose of the vaccine, a placebo patch, or an approved measles-rubella vaccine given with an injection under the skin. After 28 days, the authors report that compared to the beginning of the trial, low-dose vaccine patches generated neutralizing antibodies against measles and rubella at about the same rate (38%) as the conventional vaccine (36%), and twice the rate of the high-dose patches, 19 to 25 percent. The authors say previous vaccination or exposure to measles and rubella created a higher baseline for comparison.

Other findings show patch vaccine recipients displayed at most mild to moderate adverse effects. And the vaccines in the devices were still considered usable even after transported for three days at 40 degrees C or 104 degrees F.

“Measles and rubella remain significant health concerns in many parts of the world,” says Vaxxas CEO David Hoey in a company statement released through BusinessWire, “and we look forward to moving this product forward to later stage clinical trials.” Among the later stage trials, says the company, is an early- and mid-stage study in The Gambia in west Africa among children not yet vaccinated for measles or rubella.

Vaxxas is following a similar strategy for its vaccine patch device as Micron Biomedical Inc., developer of a peel-and-stick patch for vaccines. Science & Enterprise reported in May 2023 on that company’s clinical trial in The Gambia showing its patch vaccine for measles and rubella generated comparable immune responses as conventional injections.

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