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| Name | Class |
|---|---|
| SID Technologies | UNKNOWN |
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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
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:
Intradermal administration of each injection will be assessed:
Injections will be assessed for safety by observation of injection sites for any local adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline injection with ID adapters | Experimental | Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID adapter (autodisable) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 30 minutes and within 48 hours of injection |
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Inclusion Criteria:
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.
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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 | Saline Injection With ID Adapters | Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy adults aged 18-55 years.
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Injection With ID Adapters | Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | Posted | Number | Injections | 1 day | Injections | Participants |
|
2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
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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 | ADID Deltoid | Injections given with the autodisable ID adapter in the deltoid region |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local AE at injection site 30 minutes after injection | Skin and subcutaneous tissue disorders | Systematic Assessment | Local AEs reported included pain, redness, bruising, and abrasion. All were minor and resolved within 1 day following injections. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Jarrahian | PATH | 206-285-3500 | cjarrahian@path.org |
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|
| ID adapter (side load) | Device | Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Injections given with the autodisable ID adapter in the suprascapular region |
| OG003 | SLA Deltoid | Injections given with the side-load ID adapter in the deltoid region |
| OG004 | SLA Forearm | Injections given with the side-load ID adapter in the forearm |
| OG005 | SLA Suprascapular | Injections given with the side-load ID adapter in the suprascapular region |
|
|
| 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. | Posted | Number | percentage of injections | Within 30 minutes and within 48 hours of injection | Injections | Participants |
|
|
|
| 0 |
| 30 |
| 11 |
| 30 |
| EG001 | ADID Forearm | Injections given with the autodisable ID adapter in the forearm region | 0 | 30 | 12 | 30 |
| EG002 | ADID Suprascapular | Injections given with the autodisable ID adapter in the suprascapular region | 0 | 30 | 10 | 30 |
| EG003 | SLA Deltoid | Injections given with the side-load ID adapter in the deltoid region | 0 | 30 | 10 | 30 |
| EG004 | SLA Forearm | Injections given with the side-load ID adapter in the forearm region | 0 | 30 | 14 | 30 |
| EG005 | SLA Suprascapular | Injections given with the side-load ID adapter in the suprascapular region | 0 | 30 | 12 | 30 |
|
| Abrasion at injection site immediately after injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Drop of blood at injection site immediately after injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Systemic AE | General disorders | Systematic Assessment |
|
| Local AEs at injection site 2 days after injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The sponsor, funder, and PI of this study have jointly published the results.