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A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy Adults

NCT07624669 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-03

No results posted yet for this study

Summary

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.

Conditions

  • Vaccine Delivery
  • Tetanus

Interventions

DEVICE

Microneedle Patch

The Miracus™ Patch is a microneedle-based patch platform for alternative drug delivery.

BIOLOGICAL

Tetanus-containing vaccine

Vaccine loaded into Miracus device for one administration

Sponsors & Collaborators

  • Microneedle Solutions Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-09-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624669 on ClinicalTrials.gov