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    Flu “patch” as effective as shots, preferred by patients

    There are many reasons why patients might avoid vaccination, but the development of a new patch may help.

    A microneedle patch (MNP) has been developed that does not require refrigeration or sharps disposal, could be mailed to patients for self-administration and may appeal to individuals who hate shots. The patch was tested through a Phase I clinical trial, and results were recently published in the Lancet in a study titled, “The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial.”

    The clinical trial involved 100 adults aged 18 to 49 without significant dermatological disorders who had not yet received the 2014-2015 flu vaccine. Participants were split into four groups—those vaccinated with inactivated influenza vaccine through a MNP applied by a healthcare provider; participants who self-administered a MNP; those vaccinated with an intramuscular injection given by a healthcare provider; and those given a placebo MNP by a healthcare provider.

    The trial was completed by researchers at Emory University and the Georgia Institute of Technology. Participants were treated and monitored at the Hope Clinic of the Emory Vaccine Center in Atlanta.

    Nadine Rouphael, MD, an associate professor of medicine in the division of infectious diseases at Emory and lead investigator for the trial, said the patch could allow patients to self-administer the vaccine at home without any special needs such as refrigeration or sharps disposal.

    “Because the MNPs are easy to use, stable at room temperature and leave no sharp waste, they are ideal for self-administration outside the healthcare system,” Rouphael told Medical Economics. “When patients can self-administer the microneedle patch from the comfort of their home without any special need, it has the potential to improve access to flu vaccines and therefore coverage.”

    The safety profile of the MNP is similar to traditional vaccination via syringe, she said, and the immune response is comparable as well.
    “The immune response is similar to the regular flu shot. The skin is an immunologically rich organ and therefore potentially a better target for many vaccines,” Rouphael said.

    No treatment-related serious adverse events or new-onset chronic illnesses were observed in the study group, according to the report. Sixteen of the 25 patients who received intramuscular injections during the trial reported tenderness, and 11 out of 25 reported pain. In contrast, 33 out of 50 patients vaccinated with the MNP reported tenderness, 20 out of 50 reported erythema, and 41 out of 50 reported pruritus.

    In terms of antibody response, titer levels at day 28 post-vaccination were similar in participants vaccinated with an intramuscular injection and with the MNP—administered either by a healthcare provider or self-administered by the participant. Seroconversion rates were significantly higher at day 28 after microneedle patch vaccination compared with placebo and were similar to vaccinations given via intramuscular injection, according to the report.


    Next: Possible boost to vaccinations

    Rachael Zimlich, RN
    Rachael Zimlich is a freelance writer in Cleveland, Ohio. She writes regularly for Contemporary Pediatrics, Managed Healthcare ...


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