Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity
Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity
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DOI：
10.1016/j.vaccine.2015.06.071
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发表时间：
2015-10-26
期刊：
影响因子：
5.5
通讯作者：
Sutter, Roland W.
中科院分区：
文献类型：
--
作者：
Resik, Sonia;Tejeda, Alina;Sutter, Roland W.
简介：世界卫生组织建议，作为脊灰终局战略的一部分，到2015年底在目前仅使用口服脊灰病毒疫苗（OPV）的所有国家引入一剂灭活脊灰病毒疫苗（IPV）。通过皮内（ID）注射施用部分剂量（全剂量的1/5）IPV（fIPV）可以降低成本，但是其常规施用是使用卡介苗（BCG）针头和注射器（NS），这是耗时的并且技术上具有挑战性。我们比较了BCG NS和三个无针喷射注射器实现的注射质量和评估人体工程学特征的injecters.Methods：儿童年龄在12和20个月之间谁曾接受口服脊髓灰质炎疫苗参加了卡马圭，古巴的研究。受试者接受单次fIPV剂量，皮内给予BCG NS或三种无针注射器装置之一：Bioject Biojector 2000（R）（B2000）、Bioject ID Pen（R）（ID Pen）或PharmaJet Tropis（R）（Tropis）。我们测量了滤过泡直径和疫苗损失作为ID注射质量的指标，理想的注射质量定义为滤过泡直径>= 5 mm和疫苗损失
Introduction: The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors.Methods: Children between 12 and 20 months of age who had previously received OPV were enrolled in the Camaguey, Cuba study. Subjects received a single fIPV dose administered intradermally with BCG NS or one of three needle-free injector devices: Bioject Biojector 2000 (R) (B2000), Bioject ID Pen (R) (ID Pen), or PharmaJet Tropis (R) (Tropis). We measured bleb diameter and vaccine loss as indicators of ID injection quality, with desirable injection quality defined as bleb diameter >= 5 mm and vaccine loss