Injections, Intradermal
Conditions
Keywords
Intradermal injections, Vaccine delivery devices
Brief summary
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
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.
Interventions
DEVICEID 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.
DEVICEID 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.
Sponsors
SID Technologies
PATH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Injections Delivered to the Intradermal Layer of the Skin | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Injections With Safety Events | Within 30 minutes and within 48 hours of injection | The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Saline Injection With ID Adapters |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 38 years |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 30 | 12 / 30 | 10 / 30 | 10 / 30 | 14 / 30 | 12 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADID Deltoid | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 28 Injections |
| ADID Deltoid | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 28 Injections |
| ADID Forearm | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 30 Injections |
| ADID Forearm | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 30 Injections |
| ADID Suprascapular | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 30 Injections |
| ADID Suprascapular | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 29 Injections |
| SLA Deltoid | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 30 Injections |
| SLA Deltoid | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 30 Injections |
| SLA Forearm | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 30 Injections |
| SLA Forearm | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 30 Injections |
| SLA Suprascapular | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Wheal diameter >=5mm | 30 Injections |
| SLA Suprascapular | Proportion of Injections Delivered to the Intradermal Layer of the Skin | Leakage <=10% | 30 Injections |
Secondary
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.
Time frame: Within 30 minutes and within 48 hours of injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADID Deltoid | Proportion of Injections With Safety Events | Local AE at 30 minutes post-injection | 5.6 percentage of injections |
| ADID Deltoid | Proportion of Injections With Safety Events | Local AE at 2 days post-injection | 0 percentage of injections |
| ADID Forearm | Proportion of Injections With Safety Events | Local AE at 30 minutes post-injection | 4.4 percentage of injections |
| ADID Forearm | Proportion of Injections With Safety Events | Local AE at 2 days post-injection | 0 percentage of injections |