The purpose of this research study is to check whether the MNS Miracus Patch (the study's investigational device, a small patch made up of microneedles that dissolve in the skin and can potentially deliver vaccines in a pain-free way) is safe to use and tolerated by humans when administered for 10 minutes, both as a plain patch (with no vaccine) and as a loaded patch (with the tetanus- containing vaccine included). This study will also investigate whether the patch delivers the correct dose of the vaccine in the loaded patches by checking the immune response of participants. As the device has not been tested clinically in humans before, this will be a first-in-human study involving healthy participants only, who have not previously received the full course of tetanus diphtheria vaccinations. This research study will take approximately 4-6 weeks of the participants' time. The study consists of a screening period up to 2 weeks to determine if participants are eligible for the study. Upon confirmation of eligibility, participants will enter the 'double-blind' study where they will receive one patch in clinic. Double-blind means that neither the participant nor the study doctor will know if the individual is receiving the empty or loaded patch. Participants will be randomly selected to receive the empty or loaded patch, and the number of participants will be equal in each group. During the study, participants will be asked to complete questionnaires, have photographs taken of their skin, give blood and urine samples and undergo general health checks including physical exam and vital signs. The clinical trial is funded by Microneedle Solutions Ltd. And Innovate UK, and will recruit 30 participants at one site in the UK only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
The Miracus™ Patch is a microneedle-based patch platform for alternative drug delivery.
Vaccine loaded into Miracus device for one administration
Local and systemic adverse events of the Miracus patch (both loaded and unloaded) (safety)
The primary outcome measure is assessment of local reactions and adverse event reporting assessed by CTCAE v6.0 through to Day 28 post- administration.
Time frame: 28 Days
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Assessed via participant reported outcome visual analogue scale (VAS) scoring for itching and irritation from 0-10cm with higher score meaning a worse outcome.
Time frame: 28 Days
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Assessed via participant reported outcome Wong-Baker scale scoring for pain from 0-10 with higher score meaning a worse outcome.
Time frame: 28 Days
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Diary card symptoms from moment of application through to Day 7 post-application
Time frame: 7 Days
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