Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.

A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.

The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations

Study Overview

• Status: Completed
• Conditions: Injections, Intradermal
• Intervention / Treatment: Device: ID adapter (autodisable); Device: ID adapter (side load)

Detailed Description

This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).

Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:

• Upper deltoid with the side-load ID adapter
• Upper deltoid with the autodisable (AD) ID adapter
• Suprascapular (behind the shoulder) with the side-load ID adapter
• Suprascapular with the AD ID adapter
• Forearm with the side-load ID adapter
• Forearm with the AD ID adapter

Intradermal administration of each injection will be assessed:

• The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
• The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
• A photo of the injection site will be taken.

Injections will be assessed for safety by observation of injection sites for any local adverse events.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female and male participants ages 18 to 55 years.
• Healthy enough to participate in the clinical trial per site investigator assessment.
• Healthy skin on the upper deltoid, suprascapular, and forearm regions (both sides of the body).
• Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
• Literate in English.
• Available by telephone 48 hours after the study visit.

Exclusion Criteria:

- Skin abnormalities on upper deltoid, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Saline injection with ID adapters; Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin: Upper deltoid with the side-load ID adapter; Upper deltoid with the AD ID adapter; Suprascapular (behind the shoulder) with the side-load ID adapter; Suprascapular with the AD ID adapter; Forearm with the side-load ID adapter; Forearm with the AD ID adapter

Device: ID adapter (autodisable); Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.; Other Names: Autodisable intradermal adapter; AD ID adapter; Device: ID adapter (side load); Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Injections Delivered to the Intradermal Layer of the Skin	The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Injections With Safety Events	The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.	Within 30 minutes and within 48 hours of injection

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: SID Technologies

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (ESTIMATE): September 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 2, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Intradermal injections; Vaccine delivery devices
• Other Study ID Numbers: HS 720