Clinical trial NCT03207763: Microneedle Patch Study in Healthy Infants/Young Children
Official title: A Study to Evaluate the Safety, Reactogenicity, and Acceptability of a Placebo Microneedle Patch in Healthy Infants and Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Skin Absorption
Keywords: Safety
Reactogenicity
Acceptability
Microneedle patch
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Micron Biomedical, Inc
First posted: 2017-07-05
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE).
timeFrame: Day 1 through the Final Study Visit (Day 27 - 38)
measure: Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
timeFrame: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
measure: Number of Participants With Solicited Application Site Reactogenicity Events.
timeFrame: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
Secondary outcomes:
measure: Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse Events
timeFrame: Day 1 through the Final Study Visit (Day 27 - 38)
measure: Number of New-onset Medical Conditions (NOMC)
timeFrame: Day 1 through the Final Study Visit (Day 27 - 38).
measure: Acceptability of Vaccination Methods
timeFrame: Final Visit (Day 27 - 38)
measure: Overall Experience
timeFrame: Day 1, Day 2, Day 8, Final Visit (Day 27-38)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Evan Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: