Microneedle patches: usability and acceptability for self-vaccination against influenza.

Microneedle patches: usability and acceptability for self-vaccination against influenza.
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DOI:
10.1016/j.vaccine.2014.01.076
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发表时间:
2014-04-01
期刊:
影响因子:
5.5
通讯作者:
Prausnitz, Mark R.
Prausnitz, Mark R.
中科院分区:
医学3区
文献类型:
--
作者:
Norman, James J.;Arya, Jaya M.;McClain, Maxine A.;Frew, Paula M.;Meltzer, Martin I.;Prausnitz, Mark R.

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虽然治疗药物通常由患者自行给药,但很少有自行接种疫苗的先例。方便的自我接种可以扩大疫苗接种覆盖面,降低管理成本。许多疫苗的针头贴片正在开发中,但没有关于可用性或可接受性的报告。我们假设初治患者可以使用贴剂,并且自我施用贴剂将改善接受流感疫苗的既定意图。我们对91名场地招募的成年人进行了随机重复测量研究。为了模拟疫苗接种,受试者接受安慰剂微针贴片,自我给药三次,研究者给药一次,以及肌肉注射生理盐水。70名参与者仅用拇指压力插入贴片,其余的使用基于按扣的设备,在一定的力下关闭。通过皮肤染色评估可用性,并采用自适应选择分析测量可接受性。Snap装置的可用性最好,用户在三次重复中插入的微针的中位数为93-96%。当提供自我施用的微针贴片时,接种疫苗的意图从44%增加到65%(CI:55-74%)。大多数打算接种疫苗的人更喜欢自我接种:64%(CI:51-75%)。没有与使用微针贴片相关的严重不良事件。这项初步研究的结果表明,用于流感自我疫苗接种的微针贴片是可用的,并且可能会提高疫苗接种覆盖率。
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.
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发表时间: 2012-06-13
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