Performance and Safety Evaluation of an Intradermal Delivery Device

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Performance and Safety Evaluation of an Intradermal Delivery Device

Conditions
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Injections, Intradermal

Intervention / Treatment
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* Device: PATH ID Adapter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PATH ID Adapter|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?
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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 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Safety Events | The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection. | 2 days | 
| Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin. | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intradermal injections, Vaccination