title: Microneedle patches: usability and acceptability for self-vaccination against influenza.
abstract: While therapeutic drugs are routinely self-administered by patients, there is little precedent for self-vaccination. Convenient self-vaccination may expand vaccination coverage and reduce administration costs. Microneedle patches are in development for many vaccines, but no reports exist on usability or acceptability. We hypothesized that naïve patients could apply patches and that self-administered patches would improve stated intent to receive an influenza vaccine. We conducted a randomized, repeated measures study with 91 venue-recruited adults. To simulate vaccination, subjects received placebo microneedle patches given three times by self-administration and once by the investigator, as well as an intramuscular injection of saline. Seventy participants inserted patches with thumb pressure alone and the remainder used snap-based devices that closed shut at a certain force. Usability was assessed by skin staining and acceptability was measured with an adaptive-choice analysis. The best usability was seen with the snap device, with users inserting a median value of 93-96% of microneedles over three repetitions. When a self-administered microneedle patch was offered, intent to vaccinate increased from 44% to 65% (CI: 55-74%). The majority of those intending vaccination would prefer to self-vaccinate: 64% (CI: 51-75%). There were no serious adverse events associated with use of microneedle patches. The findings from this initial study indicate that microneedle patches for self-vaccination against influenza are usable and may lead to improved vaccination coverage.
authors: Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, 315 Ferst Drive, Atlanta, GA 30332, USA. Electronic address: jnorman3@gatech.edu.
authors: James J
authors: JJ
authors: Norman
authors: Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, 315 Ferst Drive, Atlanta, GA 30332, USA. Electronic address: jarya3@gatech.edu.
authors: Jaya M
authors: JM
authors: Arya
authors: Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, 315 Ferst Drive, Atlanta, GA 30332, USA. Electronic address: mx.mcclain@gmail.com.
authors: Maxine A
authors: MA
authors: McClain
authors: Emory University, School of Medicine, Division of Infectious Diseases, 1364 Clifton Road, Atlanta, GA 30322, USA; Emory University, Rollins School of Public Health, Department of Behavioral Sciences & Health Education, 1518 Clifton Road, Atlanta, GA 30332, USA. Electronic address: pfrew@emory.edu.
authors: Paula M
authors: PM
authors: Frew
authors: Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, 1600 Clifton Road, Atlanta, GA 30333, USA. Electronic address: qzm4@cdc.gov.
authors: Martin I
authors: MI
authors: Meltzer
authors: Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, 315 Ferst Drive, Atlanta, GA 30332, USA. Electronic address: prausnitz@gatech.edu.
authors: Mark R
authors: MR
authors: Prausnitz
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007251:Influenza, Human / Q000517:prevention & control; D007271:Injections, Intradermal / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D009339:Needles; D057240:Patient Preference; D012646:Self Administration / Q000295:instrumentation*; D057968:Transdermal Patch; D014611:Vaccination / Q000295:instrumentation*; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines
keywords: Acceptability; Influenza; Microneedle, Human study; Usability