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| Name | Class |
|---|---|
| Micron Biomedical, Inc | INDUSTRY |
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Microneedles can be prepared as a low-cost patch that is simple for patients to apply for vaccine delivery targeting the many antigen-presenting cells present in the skin. Data regarding the safety, reactogenicity, tolerability, and acceptability of a microneedle patch in children are lacking. The goal of this study is to evaluate the safety, reactogenicity, and acceptability of placement of a placebo microneedle patch to the skin of children.
Available vaccine delivery methods include intramuscular or subcutaneous injection are limited by patient needle phobia and the need for trained medical personnel. Alternative routes of vaccination that avoid hypodermic needles have previously been poorly immunogenic, require live vaccines, utilize bulky devices and/or are unsuitable for self-administration. Novel vaccine delivery methods such as microneedles can render vaccination easier and more acceptable to the public by simplifying vaccine access. Microneedles are micron-scale needles that administer vaccine directly into the skin using a simple minimally invasive approach without generating sharps waste. This study is designed to investigate the safety, reactogenicity, and acceptability of a placebo microneedle patch in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participating infants and children will receive Microneedle Formulation 1. At least 4 infants or children must complete Day 8 without halting criteria having been met before subjects will be enrolled into the next younger age group within a Cohort. At least the first 2 children will have a microneedle patch initially applied to the skin overlying the shoulder blade. If this site is well tolerated without halting criteria having been met additional microneedle patches may be applied to the same participants and in subsequent participants to the upper arm, forearm, wrist and/or thigh. |
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| Cohort 2 | Experimental | Participating infants and children will receive Microneedle Formulation 2. At least 4 infants or children must complete Day 8 without halting criteria having been met before subjects will be enrolled into the next younger age group within a Cohort. At least the first 2 children will have a microneedle patch initially applied to the skin overlying the shoulder blade. If this site is well tolerated without halting criteria having been met additional microneedle patches may be applied to the same participants and in subsequent participants to the upper arm, forearm, wrist and/or thigh. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle Formulation 1 | Device | Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The total mass of excipients delivered by placebo microneedle patch will be <1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin). Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE). | To evaluate safety following application of the patch topically, microneedle patch-related serious adverse events were recorded. Information collected included event description, date of onset, severity and date of resolution/stabilization of the event. Severity and relationship to study product was assessed by the Investigator or sub-investigator. | Day 1 through the Final Study Visit (Day 27 - 38) |
| Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE). | The occurrence of Grade 3 solicited adverse events related to the placebo microneedle patch was recorded. Solicited adverse events were irritability (fussiness), lethargy (drowsiness), decreased appetite, vomiting, and fever. The severity of these adverse events was graded on a scale from 0 to 3 where 0 = not present and 3 = significant, preventing daily activity or a fever of >102.1 degrees Fahrenheit (F). | Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3 |
| Number of Participants With Solicited Application Site Reactogenicity Events. | The occurrence of solicited reactogenicity events at the application site was recorded. The solicited reactogenicity events are reactions that are common or expected to occur with application of a microneedle patch and include induration/swelling, erythema, ecchymosis, itching, pain, and tenderness. The Legally Authorized Representatives (LARs) of participants were provided with a memory aid, thermometer and ruler to record the presence of solicited symptoms and oral temperature. Reactogenicity event details were collected via review of the subject's memory aid and by interview with the subject LAR. Reactogenicity events were graded on a scale from 0 (not present) to 3 (significant or severe). | Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse Events | Grade 3, patch-related unsolicited adverse events (AEs) were recorded. An adverse event is graded as Grade 3 if the event is significant or prevents daily activity. | Day 1 through the Final Study Visit (Day 27 - 38) |
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Inclusion Criteria:
Exclusion Criteria:
Subject has an acute illness with fever (temperature >100.4 °F) within 72 hours prior to enrollment.
Subject has a known chronic medical problem.
Subject has known immunosuppression due to underlying illness or treatment, including (but not limited to): Human Immunodeficiency Virus (or birth to a HIV-positive mother), hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy or radiation therapy; congenital immunodeficiency, anatomical or functional asplenia.
Subject has used long-term* high-dose** oral or parenteral glucocorticoids, or high-dose inhaled steroids.***
* Long term is defined as taken for 2 weeks or more in total at any time during the past 2 months.
** High dose defined as prednisone ≥ 20 mg total daily dose, or equivalent dose of other glucocorticoids.
*** High dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent.
Subject has a history of an underlying skin condition (e.g., eczema, atopic dermatitis) or an open lesion (e.g., laceration, abrasion), scar, or rash in the areas of the planned microneedle patch administration which will interfere with the assessment of reactogenicity.
Subject or family members have a history of keloid formation.
Subject has any condition that, in the opinion of the investigator, may put the subject at increased risk of harm, may cause the subject to be unable to meet the requirements or might otherwise interfere with evaluations required by the study.
Subject has received any experimental products within 30 days before study entry or plan to receive experimental products at any time during the study.
Subject has received a vaccine within 7 days of enrollment or plans to receive a vaccine within 7 days after enrollment.
Subject has previously received immunoglobulin or blood products.
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| Name | Affiliation | Role |
|---|---|---|
| Evan Anderson, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
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Participants were enrolled at the Emory Children's Center in Atlanta, Georgia. Enrollment began on July 11, 2017 and all follow up was complete by May 15, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
| FG001 | Cohort 2 | Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE). | To evaluate safety following application of the patch topically, microneedle patch-related serious adverse events were recorded. Information collected included event description, date of onset, severity and date of resolution/stabilization of the event. Severity and relationship to study product was assessed by the Investigator or sub-investigator. | Posted | Count of Participants | Participants | Day 1 through the Final Study Visit (Day 27 - 38) |
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Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
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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 | Cohort 1 | Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bug bite | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Anderson, MD | Emory University | 404-727-1746 | evanderson@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2019 | Sep 25, 2020 | Prot_SAP_000.pdf |
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| Microneedle Formulation 2 | Device | Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The ratio of the excipients and excipients used will vary slightly from Formulation 1. The total mass of excipients delivered by placebo microneedle patch will be <1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin). Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches. |
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| Number of New-onset Medical Conditions (NOMC) |
The number of new-onset medical conditions (NOMC) were recorded. NOMC were tabulated by overall and treatment related events. |
| Day 1 through the Final Study Visit (Day 27 - 38). |
| Acceptability of Vaccination Methods | LARs were asked to state their preference for different methods of vaccine delivery, assuming that a vaccine patch were to be available in the next two years. LARs reported their preference for their child receiving 1) a vaccine by shot or nasal spray given by a healthcare worker, 2) a vaccine patch given by a healthcare worker, 3) a vaccine patch given by the LAR but monitored by a healthcare worker, or 4) a vaccine patch given by the LAR at home. LARs rated their preference on a scale from 0 (definitely not) to 10 (definitely so). | Final Visit (Day 27 - 38) |
| Overall Experience | LARs were asked to report their overall experience with the study so far at each study visit related to Patch 1. Experiences were rated on a scale from 1 to 5 where 1 = very negative and 5 = very positive. | Day 1, Day 2, Day 8, Final Visit (Day 27-38) |
| BG001 | Cohort 2 | Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Cohort 2 | Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. |
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| Primary | Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE). | The occurrence of Grade 3 solicited adverse events related to the placebo microneedle patch was recorded. Solicited adverse events were irritability (fussiness), lethargy (drowsiness), decreased appetite, vomiting, and fever. The severity of these adverse events was graded on a scale from 0 to 3 where 0 = not present and 3 = significant, preventing daily activity or a fever of >102.1 degrees Fahrenheit (F). | The memory aid to log solicited adverse events was not returned for one participant in Cohort 1 receiving the first patch. The memory aid was not returned for two participants in Cohort 1 receiving the second and third patches. | Posted | Count of Participants | Participants | Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3 |
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| Primary | Number of Participants With Solicited Application Site Reactogenicity Events. | The occurrence of solicited reactogenicity events at the application site was recorded. The solicited reactogenicity events are reactions that are common or expected to occur with application of a microneedle patch and include induration/swelling, erythema, ecchymosis, itching, pain, and tenderness. The Legally Authorized Representatives (LARs) of participants were provided with a memory aid, thermometer and ruler to record the presence of solicited symptoms and oral temperature. Reactogenicity event details were collected via review of the subject's memory aid and by interview with the subject LAR. Reactogenicity events were graded on a scale from 0 (not present) to 3 (significant or severe). | Memory aids were not returned for one participant in Cohort 1 for Patch 1 and two participants in Cohort 1 receiving Patches 2 and 3. | Posted | Count of Participants | Participants | Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3 |
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| Secondary | Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse Events | Grade 3, patch-related unsolicited adverse events (AEs) were recorded. An adverse event is graded as Grade 3 if the event is significant or prevents daily activity. | Posted | Count of Participants | Participants | Day 1 through the Final Study Visit (Day 27 - 38) |
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| Secondary | Number of New-onset Medical Conditions (NOMC) | The number of new-onset medical conditions (NOMC) were recorded. NOMC were tabulated by overall and treatment related events. | Posted | Number | new-onset medical conditions | Day 1 through the Final Study Visit (Day 27 - 38). |
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| Secondary | Acceptability of Vaccination Methods | LARs were asked to state their preference for different methods of vaccine delivery, assuming that a vaccine patch were to be available in the next two years. LARs reported their preference for their child receiving 1) a vaccine by shot or nasal spray given by a healthcare worker, 2) a vaccine patch given by a healthcare worker, 3) a vaccine patch given by the LAR but monitored by a healthcare worker, or 4) a vaccine patch given by the LAR at home. LARs rated their preference on a scale from 0 (definitely not) to 10 (definitely so). | This analysis includes participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Final Visit (Day 27 - 38) |
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| Secondary | Overall Experience | LARs were asked to report their overall experience with the study so far at each study visit related to Patch 1. Experiences were rated on a scale from 1 to 5 where 1 = very negative and 5 = very positive. | The population in this analysis includes LARs who completed this question of the study visit survey. | Posted | Mean | Standard Deviation | units on a scale | Day 1, Day 2, Day 8, Final Visit (Day 27-38) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Cohort 2 | Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh. | 0 | 25 | 0 | 25 | 4 | 25 |
| Teething | Gastrointestinal disorders | Non-systematic Assessment |
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| Bacterial ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
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| Papular rash around site of prior microneedle patch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hyperpigmented and macular rash at site of prior microneedle patch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Viral gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Cold symptoms of viral illness | Infections and infestations | Non-systematic Assessment |
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| Significant lethargy |
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| Significantly decreased appetite |
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| Significant vomiting |
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| Fever >102.1 F |
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| Erythema Grade 0 (absent) |
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| Erythema Grade 1 (mild) |
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| Ecchymosis Grade 0 (absent) |
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| Itching Grade 0 (absent) |
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| Itching Grade 1 (mild) |
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| Pain Grade 0 (absent) |
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| Pain Grade 1 (mild) |
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| Tenderness Grade 0 (absent) |
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| Tenderness Grade 1 (mild) |
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| Patch by LAR monitored by healthcare worker |
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| Patch by LAR at home |
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| Patch 1, Day 2 |
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| Patch 1, Day 8 |
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| Patches 2 and 3, Day 8 |
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| Patches 2 and 3, Day 9 |
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| Patches 2 and 3, Day 15 |
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| All patchesFinal Visit (Day 27-38) |
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