Vaccine DeliveryPhase 4Miracus™ FIHNCT07624669
A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy Adults
A Phase 4 study testing Microneedle Patch and Tetanus-containing vaccine in people with Vaccine Delivery and Tetanus, run by Microneedle Solutions Ltd.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Delivery, Tetanus
- What is being tested?
- Microneedle Patch and Tetanus-containing vaccine
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy male or female adults aged >16 years.
- Minimum 27x27mm patch of hairless skin on the upper flexor forearm that is not affected by any clinically significant dermatological condition at the intended application site (upper flexor forearm), including but not limited to active inflammatory dermatoses (e.g., eczema, psoriasis), infection (bacterial, viral, or fungal), scarring or keloids, sun or chemical burn, pigmentary disorders that may interfere with assessment, autoimmune or bullous disease, vascular or purpuric lesions, open wounds, tattoos at the application site, or any other skin abnormality that, in the opinion of the Investigator, could interfere with study assessments or increase risk to the participant.
- Able to provide written informed consent.
- Postmenopausal women aged 45 and above who have not had a period for at least 12 months and are not using hormonal contraception.
- Females of child-bearing potential must agree to use medically approved methods for birth control including condoms with or without spermicides, hormonal contraceptives (oestrogen and/or progestin products; either oral, intrauterine, or epidermal) or intrauterine device with copper.
- Willing to comply with all study procedures and attend all scheduled visits.
Who cannot join
- Known allergy or hypersensitivity to Tetanus containing vaccine or any skin-contacting components of the Miracus™ patches (polyvinylpyrrolidone (PVP), Polycarbonate (PC), acrylic and/or silicone).
- Prior Tetanus Containing Vaccine booster within the last 12 months. .
- Participation in another IMP clinical trial within the last 30 days.
- Use of systemic immunosuppressive or immunomodulatory medication within 30 days prior to first study intervention, including but not limited to systemic corticosteroids (≥10 mg/day prednisone equivalent for >14 days), biologic agents, monoclonal antibodies, calcineurin inhibitors, antimetabolites, cytotoxic agents, or JAK inhibitors, or any other systemic or topical medications that, in the opinion of the investigator, may affect skin condition or immune response. - - Topical, inhaled, or intranasal corticosteroids are permitted if, in the opinion of the Investigator, they are not expected to result in clinically meaningful systemic immunosuppression.
- Evidence of active systemic infection, defined as clinically significant abnormalities in haematology, inflammatory markers (e.g., elevated WBC count or CRP), positive infection serology, or other laboratory findings consistent with acute infection, as determined by the Investigator.
- Pregnant or lactating female, or pregnancy planned during the trial.
- Presenting a psychological or linguistic incapacity to understand and sign the informed consent form.
- Employees of the Sponsor or study site who are directly involved in the design, conduct, oversight, or analysis of the study, and their immediate family members. Other hospital or institutional staff not involved in the study may participate, provided there is no direct supervisory or dependent relationship with study personnel.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-In-Human, Randomised, Double-Blind, Controlled Pilot Study to Evaluate the Safety and Tolerability of Microneedle Solutions Ltd's Unloaded and Fixed-Dose Tetanus- Containing Vaccine Loaded Miracus™ Patch in Healthy Adults
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.
Read more
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
- Being tested
- Microneedle Patch, Tetanus-containing vaccine
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle PatchDevice
Also called Miracus™ Patch, VH2.2
The Miracus™ Patch is a microneedle-based patch platform for alternative drug delivery.
Tetanus-containing vaccineBiological
Vaccine loaded into Miracus device for one administration
| Study group | Role | What they receive |
|---|---|---|
| Loaded Patch | Experimental | Microneedle patch loaded with Tetanus-containing vaccine Receives: Device: Microneedle Patch; Biological: Tetanus-containing vaccine |
| Unloaded Patch | Experimental | Empty patch with no active pharmaceutical ingredient Receives: Device: Microneedle Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised 1:1 to receive the unloaded (empty) patch, and loaded (tetanus-containing vaccine) patch.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microneedle Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624669
- Sponsor's protocol ID
- MNS-001
- Acronym
- Miracus™ FIH
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Randomised, Double-Blind, Controlled Pilot Study to Evaluate the Safety and Tolerability of Microneedle Solutions Ltd's Unloaded and Fixed-Dose Tetanus- Containing Vaccine Loaded Miracus™ Patch in Healthy Adults
- ClinicalTrials.gov ID
- NCT07624669
- Acronym / sponsor ID
- Miracus™ FIH / MNS-001
- Conditions
- Vaccine Delivery, Tetanus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Microneedle Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised 1:1 to receive the unloaded (empty) patch, and loaded (tetanus-containing vaccine) patch.
| Arm | Type | Receives |
|---|---|---|
| Loaded Patch | Experimental | Device: Microneedle Patch, Biological: Tetanus-containing vaccineMicroneedle patch loaded with Tetanus-containing vaccine |
| Unloaded Patch | Experimental | Device: Microneedle PatchEmpty patch with no active pharmaceutical ingredient |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female adults aged >16 years.
- Minimum 27x27mm patch of hairless skin on the upper flexor forearm that is not affected by any clinically significant dermatological condition at the intended application site (upper flexor forearm), including but not limited to active inflammatory dermatoses (e.g., eczema, psoriasis), infection (bacterial, viral, or fungal), scarring or keloids, sun or chemical burn, pigmentary disorders that may interfere with assessment, autoimmune or bullous disease, vascular or purpuric lesions, open wounds, tattoos at the application site, or any other skin abnormality that, in the opinion of the Investigator, could interfere with study assessments or increase risk to the participant.
- Able to provide written informed consent.
- Postmenopausal women aged 45 and above who have not had a period for at least 12 months and are not using hormonal contraception.
- Females of child-bearing potential must agree to use medically approved methods for birth control including condoms with or without spermicides, hormonal contraceptives (oestrogen and/or progestin products; either oral, intrauterine, or epidermal) or intrauterine device with copper.
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to Tetanus containing vaccine or any skin-contacting components of the Miracus™ patches (polyvinylpyrrolidone (PVP), Polycarbonate (PC), acrylic and/or silicone).
- Prior Tetanus Containing Vaccine booster within the last 12 months. .
- Participation in another IMP clinical trial within the last 30 days.
- Use of systemic immunosuppressive or immunomodulatory medication within 30 days prior to first study intervention, including but not limited to systemic corticosteroids (≥10 mg/day prednisone equivalent for >14 days), biologic agents, monoclonal antibodies, calcineurin inhibitors, antimetabolites, cytotoxic agents, or JAK inhibitors, or any other systemic or topical medications that, in the opinion of the investigator, may affect skin condition or immune response. - - Topical, inhaled, or intranasal corticosteroids are permitted if, in the opinion of the Investigator, they are not expected to result in clinically meaningful systemic immunosuppression.
- Evidence of active systemic infection, defined as clinically significant abnormalities in haematology, inflammatory markers (e.g., elevated WBC count or CRP), positive infection serology, or other laboratory findings consistent with acute infection, as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle PatchAlso: Miracus™ Patch, VH2.2The Miracus™ Patch is a microneedle-based patch platform for alternative drug delivery. | Device | Loaded Patch, Unloaded Patch |
| Tetanus-containing vaccineVaccine loaded into Miracus device for one administration | Biological | Loaded Patch |
Primary outcome
Local and systemic adverse events of the Miracus patch (both loaded and unloaded) (safety)
Time frame: 28 Days
The primary outcome measure is assessment of local reactions and adverse event reporting assessed by CTCAE v6.0 through to Day 28 post- administration.
3 secondary outcomes
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Time frame: 28 Days
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Time frame: 28 Days
Participant reported tolerability via Participant Report Outcomes (PROs) of the Miracus patch (both loaded and unloaded)
Time frame: 7 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microneedle Patch and Tetanus-containing vaccine in people with Vaccine Delivery and Tetanus, run by Microneedle Solutions Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Aldred (+44 (0)113 306 1637, anna.aldred@microneedlesolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local and systemic adverse events of the Miracus patch (both loaded and unloaded) (safety) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.