Microneedle Patch Study in Healthy Infants/Young 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.

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.