Microneedle Patch Study in Healthy Infants/Young Children
Condition: Vaccination; Skin Absorption
Study type: Interventional

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.
    

Intervention name(s): Microneedle Formulation 1; Microneedle Formulation 2
Intervention type(s): Device; Device
Intervention description(s): 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 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.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Reactogenicity; Acceptability; Microneedle patch