The National Institutes of Health–funded study led by a team at the Georgia Institute of Technology and Emory University found an experimental patch of dissolving microneedles can safely deliver influenza vaccine and produce robust immune responses.
“This bandage-strip sized patch of painless and dissolvable needles can transform how we get vaccinated,” said Roderic I. Pettigrew, PhD, MD, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which funded the study. “A particularly attractive feature is that this vaccination patch could be delivered in the mail and self-administered. In addition, this technology holds promise for delivering other vaccines in the future.”
The study was published online recently in The Lancet. The dime-sized patch of microneedles used in the trial were water-soluble and just long enough to penetrate the skin, researchers note.
“The skin is an immune surveillance organ,” explained Mark R. Prausnitz, PhD, Regents Professor and J. Erskine Love Chair in Chemical and Biomolecular Engineering at the Georgia Institute of Technology. “It’s our interface with the outside world, so it’s very well equipped to detect a pathogen and mount an immune response against it.”
The vaccine is encapsulated in the needles and released as the needle tips dissolve, within minutes, while an adhesive helps the patch grip the skin. Afterwards, the patch is peeled away and discarded like a used bandage strip.
For the National Institutes of Health–funded study, researchers enrolled 100 adult participants, dividing them into four random groups:
• Vaccination with microneedle patch given by a healthcare provider;
• Vaccination with microneedle patch self-administered by the study participant;
• Vaccination with intramuscular injection given by a healthcare provider; and
• Placebo microneedle patch given by a healthcare provider.
An inactivated influenza vaccine formulated for the 2014-2015 flu season was used to inoculate participants other than those in the placebo group.
No serious, related adverse events were reported, although some participants developed local skin reactions to the patches, described as faint redness and mild itching that lasted 2 to 3 days.
Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection and were still present after 6 months.
In addition, more than 70% of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations. Furthermore, no significant difference was detected between the doses of vaccine delivered by the healthcare workers and those self-administered.
The vaccines remained potent in the patches without refrigeration for at least 1 year. Researchers suggest the prospective vaccine technology would cost about the same to manufacture but would be less expensive to administer—since healthcare workers wouldn’t need to be involved—and requires no refrigeration or special transportation.
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