Microneedle Patch Study in Healthy Infants/Young Children

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03207763
Study type	Interventional
Source	Emory University
Contact
Status	Completed
Phase	N/A
Start date	July 11, 2017
Completion date	May 15, 2019

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