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

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.