title: Clinical performance and safety of adapters for intradermal delivery with conventional and autodisable syringes.
abstract: Although the number of vaccines and diagnostic tests currently delivered intradermally is limited, this route of administration offers potential advantages due to the high concentration of antigen-presenting cells in the skin. One factor which may in part be limiting development and use of intradermal (ID) administration is concern about the ease and reliability of the needle and syringe-based Mantoux technique. A phase I clinical study was conducted to evaluate two ID adapters that have been developed as injection-delivery aids to increase the safety, simplicity, and reliability of ID injection: a prototype autodisable, intradermal (ADID) adapter for autodisable (AD) syringes, and a marketed side-merge adapter (SMA). Thirty healthy adult volunteers each received six injections of 0.1 mL of sterile saline solution. Each adapter was used to give injections into the upper deltoid, forearm, and suprascapular regions of each volunteer. The needle-bevel orientation during injection was random. Injection performance was determined by measuring wheal size and fluid leakage. Wheals were similar in size for the ADID adapter (mean 9.9 ± 0.17 mm) and SMA (mean 9.8 ± 0.15 mm). In all of the injections completed with the SMA, and 98% of those completed with the ADID, fluid leakage was less than 10% of the intended injection volume. Minor skin abrasions were the only adverse events. Based on self-reporting of pain, injections were well tolerated (mean pain score of 2 on a 0-10 scale). ID delivery using the SMA and ADID adapters appears safe and effective.
authors.affiliation: SID Technologies, 51 Rittenhouse Cir., Newtown, PA 18940, USA. Electronic address: izzy.tsals@gmail.com.
authors.forename: Izrail
authors.initials: I
authors.lastname: Tsals
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
authors.forename: Courtney
authors.initials: C
authors.lastname: Jarrahian
authors.affiliation: SID Technologies, 51 Rittenhouse Cir., Newtown, PA 18940, USA.
authors.forename: Fred E
authors.initials: FE
authors.lastname: Snyder
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Saganic
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
authors.forename: Eugene
authors.initials: E
authors.lastname: Saxon
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
authors.forename: Darin
authors.initials: D
authors.lastname: Zehrung
authors.affiliation: West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341, USA.
authors.forename: Glen
authors.initials: G
authors.lastname: Zimmerman
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Papania
authors.affiliation: Rainier Clinical Research Center, 723 SW 10th Street, Suite 100, Renton, WA 98057, USA.
authors.forename: Leslie
authors.initials: L
authors.lastname: Klaff
mesh_terms: D000328:Adult; D016503:Drug Delivery Systems; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007271:Injections, Intradermal / Q000379:methods*; D008297:Male; D008875:Middle Aged; D013594:Syringes; D014612:Vaccines / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014612:Vaccines
keywords: Delivery technology; Intradermal; Mantoux; Vaccination