Jarrahian Courtney, Rein-Weston Annie, Saxon Gene, Creelman Ben, Kachmarik Greg, Anand Abhijeet, Zehrung Darin
PATH, PO Box 900922, Seattle, WA 98109, USA.
PATH, PO Box 900922, Seattle, WA 98109, USA.
Vaccine. 2017 Mar 27;35(14):1789-1796. doi: 10.1016/j.vaccine.2016.11.098. Epub 2017 Feb 8.
Intradermal delivery of a fractional dose of inactivated poliovirus vaccine (IPV) offers potential benefits compared to intramuscular (IM) delivery, including possible cost reductions and easing of IPV supply shortages. Objectives of this study were to assess intradermal delivery devices for dead space, wastage generated by the filling process, dose accuracy, and total number of doses that can be delivered per vial.
Devices tested included syringes with staked (fixed) needles (autodisable syringes and syringes used with intradermal adapters), a luer-slip needle and syringe, a mini-needle syringe, a hollow microneedle device, and disposable-syringe jet injectors with their associated filling adapters. Each device was used to withdraw 0.1-mL fractional doses from single-dose IM glass vials which were then ejected into a beaker. Both vial and device were weighed before and after filling and again after expulsion of liquid to record change in volume at each stage of the process. Data were used to calculate the number of doses that could potentially be obtained from multidose vials.
Results show wide variability in dead space, dose accuracy, overall wastage, and total number of doses that can be obtained per vial among intradermal delivery devices. Syringes with staked needles had relatively low dead space and low overall wastage, and could achieve a greater number of doses per vial compared to syringes with a detachable luer-slip needle. Of the disposable-syringe jet injectors tested, one was comparable to syringes with staked needles.
If intradermal delivery of IPV is introduced, selection of an intradermal delivery device can have a substantial impact on vaccine wasted during administration, and thus on the required quantity of vaccine that needs to be purchased. An ideal intradermal delivery device should be not only safe, reliable, accurate, and acceptable to users and vaccine recipients, but should also have low dead space, high dose accuracy, and low overall wastage to maximize the potential number of doses that can be withdrawn and delivered.
与肌内注射（IM）相比，皮内注射小剂量灭活脊髓灰质炎疫苗（IPV）具有潜在益处，包括可能降低成本以及缓解IPV供应短缺问题。本研究的目的是评估皮内注射装置的死腔、灌装过程产生的损耗、剂量准确性以及每个小瓶可注射的总剂量数。
测试的装置包括带有固定（铆接）针头的注射器（自动销毁注射器以及与皮内适配器一起使用的注射器）、鲁尔滑套针头和注射器、微型针头注射器、中空微针装置以及带有相关灌装适配器的一次性注射器喷射注射器。每个装置用于从单剂量IM玻璃小瓶中抽取0.1毫升的小剂量，然后将其注入烧杯中。在灌装前后以及液体排出后对小瓶和装置进行称重，以记录该过程每个阶段的体积变化。数据用于计算从多剂量小瓶中可能获得的剂量数。
结果表明，皮内注射装置在死腔、剂量准确性、总体损耗以及每个小瓶可获得的总剂量数方面存在很大差异。带有固定针头的注射器死腔相对较小，总体损耗较低，与带有可拆卸鲁尔滑套针头的注射器相比，每个小瓶可实现更多剂量。在所测试的一次性注射器喷射注射器中，有一种与带有固定针头的注射器相当。
如果引入IPV皮内注射，皮内注射装置的选择可能会对给药过程中浪费的疫苗产生重大影响，从而对需要购买的疫苗数量产生影响。理想的皮内注射装置不仅应安全、可靠、准确且为使用者和疫苗接种者所接受，还应具有低死腔、高剂量准确性和低总体损耗，以最大限度地提高可抽取和注射的潜在剂量数。
