Injections, Intradermal
Conditions
Keywords
Intradermal injections, Vaccination
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.
Interventions
DEVICEPATH 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.
Sponsors
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 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.
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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intradermal Adapter Saline injection with intradermal adapter | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intradermal Adapter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 35.4 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intradermal Adapter | Proportion of Injections Delivered to the Intradermal Layer of the Skin | 1 percentage of injections |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intradermal Adapter | Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin. | 1 percentage of injections |
| Bevel Down | Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin. | 1 percentage of injections |
Secondary
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.
Time frame: 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intradermal Adapter | Proportion of Participants With Safety Events | 0.25 percentage of participants |