Safety, Reactogenicity, and Acceptability of a Placebo Dissolving Microneedle Patch in Children

Background and Objectives Dissolving microneedle patches (dMNPs) are a novel vaccine delivery method that may enhance acceptability and uptake. However, more data on their use in children is needed. Methods We performed a single-center, unblinded study at Emory University to evaluate the safety, reactogenicity, and acceptability of placebo dMNPs applied to the skin of healthy infants and children. Each participant received a dMNP on Day 1, and if well tolerated, could receive second and third dMNPs on Day 8 applied to different anatomical sites. Solicited local and systemic adverse events (AEs) were collected for 7 days following dMNP application. Unsolicited AEs, serious adverse events (SAEs), and new-onset medical conditions (NOMCs) were collected through the study. Parents were surveyed to assess dMNP acceptability. Results Between August 2018 and April 2019, 25 participants 6 weeks to 24 months of age were enrolled. All participants received one placebo dMNP applied to the wrist, and 23/25 received second and third placebo dMNPs. Overall, dMNPs were safe and well tolerated with minimal local reactogenicity. Systemic reactogenicity was generally mild but Grade 2 and 3 irritability were observed. There were no SAEs or NOMCs following the application of any dMNP. Parental acceptability of dMNPs was high, and parents reported that having a dMNP administered by a healthcare worker would increase their likelihood of obtaining a recommended vaccine for their child. Conclusions Placebo dMNPs were safe and well-tolerated in infants and young children. These data support the continued development of pediatric dMNP vaccines.