VaccinationNCT03207763
Microneedle Patch Study in Healthy Infants/Young Children
A study testing Microneedle Formulation 1 and Microneedle Formulation 2 in people with Vaccination and Skin Absorption, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 weeks to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Skin Absorption
- What is being tested?
- Microneedle Formulation 1 and Microneedle Formulation 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Legally Authorized Representative (LAR) provides written informed consent prior to any study procedures being performed.
- Subject is between the ages of 6 weeks and 24 months, inclusive, on the day of signing informed consent.
- Subject is in good health as determined by vital signs, medical history, and a targeted physical examination.
- LAR is able to understand and comply with required study procedures.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Reactogenicity, and Acceptability of a Placebo Microneedle Patch in Healthy Infants and Young Children
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.
Read the detailed description
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.
- Conditions
- Vaccination, Skin Absorption
- Being tested
- Microneedle Formulation 1, Microneedle Formulation 2
- Keywords
- Safety, Reactogenicity, Acceptability, Microneedle patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle Formulation 1Device
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.
Microneedle Formulation 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Microneedle Formulation 1 |
| 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. Receives: Device: Microneedle Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
Secondary outcomes (4)
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.
Measured: Day 1 through the Final Study Visit (Day 27 - 38)
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.
Measured: 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).
Measured: 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.
Measured: Day 1, Day 2, Day 8, Final Visit (Day 27-38)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start11 Jul 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Micron Biomedical, Inc
- Responsible party
- Principal investigator, Evan Anderson, Emory University
- Investigators
- Evan Anderson, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207763
- Sponsor's protocol ID
- IRB00096635
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2017
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Reactogenicity, and Acceptability of a Placebo Microneedle Patch in Healthy Infants and Young Children
- ClinicalTrials.gov ID
- NCT03207763
- Acronym / sponsor ID
- IRB00096635
- Conditions
- Vaccination, Skin Absorption
- Keywords
- Safety, Reactogenicity, Acceptability, Microneedle patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Micron Biomedical, Inc
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: Microneedle Formulation 1Participating 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. |
| Cohort 2 | Experimental | Device: Microneedle Formulation 2Participating 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. |
Who may qualify
- Ages
- 6 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Legally Authorized Representative (LAR) provides written informed consent prior to any study procedures being performed.
- Subject is between the ages of 6 weeks and 24 months, inclusive, on the day of signing informed consent.
- Subject is in good health as determined by vital signs, medical history, and a targeted physical examination.
- LAR is able to understand and comply with required study procedures.
Key exclusion criteria (13 listed)
- 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.*
- High dose defined as prednisone ≥ 20 mg total daily dose, or equivalent dose of other glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle Formulation 1Microneedle 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. | Device | Cohort 1 |
| Microneedle Formulation 2Microneedle 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. | Device | Cohort 2 |
Primary outcome
Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE).
Time frame: Day 1 through the Final Study Visit (Day 27 - 38)
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.
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Time frame: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
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).
Number of Participants With Solicited Application Site Reactogenicity Events.
Time frame: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
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).
4 secondary outcomes
Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse Events
Time frame: Day 1 through the Final Study Visit (Day 27 - 38)
Number of New-onset Medical Conditions (NOMC)
Time frame: Day 1 through the Final Study Visit (Day 27 - 38).
Acceptability of Vaccination Methods
Time frame: Final Visit (Day 27 - 38)
Overall Experience
Time frame: Day 1, Day 2, Day 8, Final Visit (Day 27-38)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Anderson, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle Formulation 1 and Microneedle Formulation 2 in people with Vaccination and Skin Absorption, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE). (time frame: Day 1 through the Final Study Visit (Day 27 - 38)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.