Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, 315 Ferst Drive, Atlanta, GA 30332, USA.
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.
Vaccine. 2014 Apr 1;32(16):1856-62. doi: 10.1016/j.vaccine.2014.01.076. Epub 2014 Feb 11.
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.
虽然治疗药物通常由患者自行给药，但自我接种疫苗的情况却很少见。方便的自我接种可能会扩大疫苗接种的覆盖面并降低管理成本。微针贴片正在为许多疫苗开发，但没有关于可用性或可接受性的报告。我们假设，未经过训练的患者可以应用贴片，并且自我接种的贴片会提高接种流感疫苗的意愿。我们进行了一项随机、重复测量的研究，共纳入了 91 名在场所招募的成年人。为了模拟接种，受试者接受了安慰剂微针贴片，通过自我给药三次，由研究人员给药一次，以及肌内注射生理盐水。70 名参与者仅用拇指压力插入贴片，其余参与者使用在一定力下关闭的 snap 式设备。通过皮肤染色评估可用性，通过自适应选择分析衡量可接受性。使用 snap 设备时，最佳的可用性，使用者在三次重复中插入了中位数为 93-96%的微针。当提供自我管理的微针贴片时，接种疫苗的意愿从 44%增加到 65%（置信区间：55-74%）。大多数打算接种疫苗的人更愿意自我接种：64%（置信区间：51-75%）。使用微针贴片没有与严重不良事件相关。这项初步研究的结果表明，用于自我接种流感疫苗的微针贴片是可用的，并且可能会提高疫苗接种率。
