Flu Vaccine Patch Safe, Effective in First Human Trial

Microneedle patches are well-tolerated, have few adverse effects, and generated robust antibody responses, according to the results of a recent trial.

Microneedle patches have been shown to potentially improve immunogenicity, simplicity, cost-effectiveness, acceptability, and safety compared with conventional needle-and-syringe immunization.
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Recently, researchers conducted the first-in-man study of a single, dissolvable microneedle patch vaccination against influenza. The study was a randomized, partly blinded, placebo-controlled, phase 1, clinical trial that enrolled 100 immunocompetent participants, aged 18 to 49 years, naïve to the 2014 to 2015 influenza vaccine, who did not have significant dermatological disorders.

The participants were randomly assigned to 1 of 4 groups who either received a single dose of inactivated influenza vaccine by microneedle patch or intramuscular injection or placebo by microneedle patch, all administered by a healthcare provider, or a single dose via microneedle patch self-administered by the participant.

Overall, there were no treatment-related serious adverse events, no treatment-related unsolicited grade 3 or higher adverse events, and no new-onset chronic illness. Tenderness was reported by 60% of individuals who received vaccination by intramuscular injection and by 66% of those who received microneedle patch. Other adverse events in the microneedle patch group included pruritus and erythema.

Geometric mean titres were similar at day 28 in the microneedle and intramuscular healthcare provider-administered groups for the H1N1 strain, the H3N2 strain, and the B strain. Similar geometric mean titres were observed in participants who self-administered the microneedle patch. Seroconversion percentages were significantly higher at day 28 in the microneedle vaccine group compared with placebo and were similar to the intramuscular injection group.

“Use of dissolvable microneedle patches for influenza vaccination was well tolerated and generated robust antibody responses,” the researchers concluded.

—Michael Potts

Reference:

Rouphael NG, Paine M, Mosley R, et al. 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 [published online June 27, 2017]. Lancet. DOI: http://dx.doi.org/10.1016/S0140-6736(17)30575-5.