Performance and Safety Evaluation of an Intradermal Delivery Device

Phase 1

Completed

• Conditions: Injections, Intradermal

• Registration Number: NCT01359111
• Lead Sponsor: PATH

Brief Summary

The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Results First Submitted: 2012-04-16
• Results First Submitted QC: 2012-04-16
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Results First Posted: 2012-05-11
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 region of both arms.
• 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 region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
• Unable to understand the study purpose or procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Injections Delivered to the Intradermal Layer of the Skin	1 day	The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Safety Events	2 days	The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.
Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.	1 day	The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.

Trial Locations

Locations (1)

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States