Hepatitis B surface antigen incorporated in dissolvable microneedle array patch is antigenic and thermostable

Area of Science:

• Biotechnology
• Vaccinology
• Materials Science

Background:

• Syringe-based vaccine administration faces challenges, prompting research into alternative delivery methods.
• Intradermal vaccination using dissolvable microneedle arrays (MNA) presents a promising, user-friendly, and painless approach.

Purpose of the Study:

• To develop and evaluate a novel microneedle patch (MNAP) for vaccine delivery.
• To assess the immunogenicity and thermostability of a hepatitis B surface antigen (HBsAg) vaccine delivered via MNAP.

Main Methods:

• Developed a microneedle patch (MNAP) using hydroxyethyl starch (HES) and chondroitin sulphate (CS).
• Formulated HBsAg with QS-21 adjuvant within the HES-based MNAP.
• Assessed immunogenicity in swines after two doses, comparing it to a commercial vaccine.
• Evaluated MNAP thermostability by storing at elevated temperatures (37°C, 45°C, 50°C) for up to 6 months.

Main Results:

• The HES-based MNAP containing HBsAg and QS-21 adjuvant showed equivalent immunogenicity to a conventional aluminum-adjuvanted vaccine.
• Transient local skin reactions (erythema, lump, scab) were observed post-application, more pronounced with adjuvant.
• The adjuvanted antigen in the HES-based matrix retained antigenicity after 6 months at 37°C and 45°C, with only a 10% loss at 50°C.

Conclusions:

• Microneedle patch technology (MNAP) is a viable and potentially superior alternative to traditional syringe-based vaccination.
• The developed HES/CS-based MNAP offers a stable and effective platform for vaccine delivery, including adjuvanted formulations.
• Further research supports MNAP for painless, easy-to-use, and thermostable vaccine administration.