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

PATH

Status: Completed

Conditions: Injections, Intradermal

Treatments: Device: ID adapter (autodisable); Device: ID adapter (side load)

Study type: Interventional

Funder types: Other

Identifiers

NCT01943110

HS 720

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Saline injection with ID adapters

Experimental group

Description:

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

Treatment:

Device: ID adapter (side load)

Device: ID adapter (autodisable)