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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PATH ID Adapter | Device | Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Klaff, MD, PhD | Rainier Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intradermal Adapter | Saline injection with intradermal adapter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intradermal Adapter | Saline injection with intradermal adapter |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of injections | 1 day | injections | Participants |
|
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2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intradermal Adapter | Saline injection with intradermal adapter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Superficial abrasion of skin caused by the needle scratching the skin as the intradermal adapter and syringe moved horizontally along the surface of the skin prior to initial skin penetration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Jarrahian | PATH | 206-285-3500 | cjarrahian@path.org |
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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 |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| injections |
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| 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. | Posted | Number | percentage of participants | 2 days |
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| 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. | Posted | Number | percentage of injections | 1 day | injections | Participants |
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| 0 |
| 20 |
| 5 |
| 20 |
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