No-Needle tetanus shot? new patch trial begins
NCT ID NCT07624669
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This first-in-human study tests a new microneedle patch (Miracus) that dissolves in the skin to deliver a tetanus vaccine without a needle. Thirty healthy adults will receive either an empty patch or one loaded with vaccine. Researchers will check safety, tolerability, and whether the patch triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tetanus-containing vaccine
- What this could lead to
- If successful, this could lead to a pain-free way to deliver vaccines using a dissolving microneedle patch.
- What could go wrong
- This is a very early, small study (30 people) testing only safety and tolerability. It may not show that the patch delivers the vaccine effectively.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- Can a Lab-Made antibody outperform standard tetanus shots?
- One shot, six protections: can a new vaccine match current standards?
- Can a new vaccine shield older kids and adults from three deadly infections?