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纳米贴片™在中低收入国家儿童免疫中的应用的最终用户可接受性研究:一种微阵列贴片(MAP)。

End-user acceptability study of the nanopatch™; a microarray patch (MAP) for child immunization in low and middle-income countries.

机构信息

Epilinks, France.

University of Abomey-Calavi, Benin.

出版信息

Vaccine. 2019 Jul 26;37(32):4435-4443. doi: 10.1016/j.vaccine.2019.02.079. Epub 2019 Mar 16.

Abstract

A promising new delivery technology, the microarray patch (MAPs) consists of an array of small solid-coated or dissolvable needles, up to one mm in length, that administers a dry formulation of a vaccine or pharmaceutical. This study is not a real-life evaluation study but determines the anticipated acceptability of the Nanopatch™, a solid microarray patch device, in Benin, Nepal and Vietnam for vaccine delivery, and identifies factors that could improve the acceptability of the technology to increase measles immunization coverage. This study combined several evaluation methods, including simulation of vaccine administration on children and in-depth interviews with key stakeholders, healthcare workers, community health volunteers, caretakers, and community representatives. A total of 314 people participated in the study. The overall rate of total acceptability of the patch for child immunization was 92.7%. General opinions were very positive, providing clinical studies confirm that MAP administration is demonstrated to be painless, safe and effective for infectious disease prevention. The study participants were asked to consider the best strategy to introduce such vaccine delivery innovation. Firstly, delivery by skilled healthcare workers at the healthcare facilities will be preferred to establish the technology. Following this, administration by selected volunteers and outreach delivery may be possible, though under the supervision of skilled healthcare workers. This study's protocol received approval from the World Health Organization (WHO) Ethical Research Committee (ERC0002813) and the national IRB in Benin, Nepal and Vietnam.

摘要

一种有前途的新型给药技术,微阵列贴片(MAPs)由一系列长度可达 1 毫米的小型固体涂层或可溶解的针组成,用于输送疫苗或药物的干粉制剂。本研究不是现实生活中的评估研究,而是确定 Nanopatch™(一种固体微阵列贴片装置)在贝宁、尼泊尔和越南用于疫苗接种的预期可接受性,并确定可以提高该技术的可接受性以增加麻疹免疫接种覆盖率的因素。本研究结合了多种评估方法,包括在儿童身上模拟疫苗接种和对关键利益攸关方、卫生保健工作者、社区卫生志愿者、看护人和社区代表进行深入访谈。共有 314 人参加了这项研究。贴片用于儿童免疫接种的总体完全可接受率为 92.7%。普遍的观点非常积极,如果临床研究证实 MAP 给药在预防传染病方面是无痛、安全和有效的,那么这将为该技术提供支持。研究参与者被要求考虑引入这种疫苗接种创新的最佳策略。首先,在医疗保健机构由熟练的医疗保健工作者进行接种将是首选,以建立该技术。在此之后,在熟练的医疗保健工作者的监督下,选择志愿者和上门接种也可能实现。本研究的方案得到了世界卫生组织(WHO)伦理研究委员会(ERC0002813)和贝宁、尼泊尔和越南的国家 IRB 的批准。

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