Development and clinical study of a self-dissolving microneedle patch for transcutaneous immunization device

Area of Science:

• Biomaterials Science
• Immunology
• Dermatology

Background:

• Previous transcutaneous immunization (TCI) microneedle patches (MH) containing collagen showed efficacy but raised concerns for human use due to potential inflammation.
• Development of a novel, collagen-free MH (new-MH) was necessary to address safety concerns for human applications.

Purpose of the Study:

• To evaluate the fundamental properties and safety of a new collagen-free microneedle patch (new-MH) for transcutaneous immunization (TCI).
• To assess the potential of new-MH as a safe and effective delivery system for human applications.

Main Methods:

• The new-MH underwent evaluation for microneedle dissolution, skin irritation, and antigen-specific antibody production in animal models (mice/rats).
• A clinical study in healthy volunteers assessed local and systemic adverse events following new-MH application.

Main Results:

• The new-MH demonstrated effective stratum corneum penetration with minimal skin irritation, similar to the previous collagen-containing MH.
• Transcutaneous immunization using new-MH successfully induced antigen-specific antibody production, comparable to the older MH.
• No severe adverse reactions were observed in human volunteers during the clinical study.

Conclusions:

• The new-MH is confirmed as a safe transcutaneous immunization device for human use.
• These findings provide strong support for advancing to Phase I/II clinical studies with antigen-loaded new-MH.