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Measles-Rubella Patch Vaccine Shown Effective as Injection

Child receiving vaccine patch

Child receiving vaccine patch in clinical trial (Micron Biomedical)

17 May 2023. A clinical trial shows a peel-and-stick patch device is as effective as a standard syringe injection in delivering a vaccine that protects against measles and rubella. Results of the trial sponsored by Micron Biomedical Inc. in Atlanta, the device developer, are presented today at the Microneedles 2023 conference in Seattle.

Micron Biomedical says its adhesive patch is designed to provide a simple, painless alternative for administering vaccines and therapies, particularly for children and others with a fear of needles. The company says the peel-and-stick patch offers other useful features for clinics and public health, notably storage and transportation without refrigeration, ease of administration even at home without supervision from trained specialists, and greatly reduced medical waste.

Micron Bio says the patch contains microscale needles that penetrate only the most outer skin layers and rapidly dissolve, releasing their payloads into blood capillaries within a few minutes. Once in the blood, says the company, the microneedle contents generate a response from immune cells in the outer skin layers. Micron Bio says the patch can deliver active live biologics, inactivate compounds, small molecule drugs, nucleic acids, peptides, proteins, and nano- to micro-scale particles.

The Micron Biomedical technology is based on research at Emory University and Georgia Tech in Atlanta. In June 2017, Science & Enterprise reported on results of a clinical trial testing a prototype stick-on patch to deliver influenza vaccine, showing the device is safe and produced an immune response. The trial was led by Emory infectious disease professor Nadine Rouphael and Georgia Tech biomedical engineering professor Mark Prausnitz who study alternative vaccine delivery methods. Prausnitz is co-founder and chief scientist of Micron Biomedical, as well as a serial entrepreneur.

Protective levels of antibodies

The new early- and mid-stage clinical trial tested the Micron Bio patch for delivery of a vaccine against the viral diseases measles and rubella, also known as German measles but caused by a different virus. The study team from Centers for Disease Control and Prevention (CDC) and the Medical Research Council of The Gambia in West Africa enrolled 45 adults, 120 infants from 9 to 10 months old, and 120 toddlers age 15 to 18 months. The researchers cite data from World Health Organization that show in lower resource regions, measles-rubella vaccine coverage continues to be well below recommended levels.

Participants were randomly assigned to receive a commercially available measles-rubella vaccine in age-appropriate doses made by Serum Institute of India, either with the Micron Biomedical patch or conventional under-the-skin injection, or a placebo. The study team looked primarily for signs of adverse effects within the first 14 days after vaccination, as well as six months later. In addition, the researchers are taking blood samples six weeks and six months after vaccination, for concentrations of immunoglobulin G or IgG antibodies that protect against measles and rubella.

The conference paper reports on findings at the six-week mark following vaccination. Results show the measles-rubella microneedle patch recipients with no allergic reactions nor serious adverse effects from the patch. In addition, the findings show adult and children patch recipients developing antibodies, including at protective concentrations, at rates of 90 to 93 percent, similar to concentrations generated by injections.

In a company statement released through Cision, Micron Biomedical CEO Steven Damon calls the results, “a major milestone in the future of injection-free administration of necessary and potentially life-saving vaccines and therapeutics.” Edward Clark, head of immunology at The Gambia Medical Research Council, adds the results “show, for the first time, the potential for microarray patches to safely and effectively deliver vaccines to children.”

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