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<p>Varicella-zoster virus (VZV) infection remains a significant pediatric health concern, and current live-attenuated vaccines are limited by cold-chain requirements, reactivation risk, and injection-related anxiety. To address these challenges, we developed and evaluated two recombinant VZV glycoprotein E (gE) microneedle (MN) platforms—coated microneedles (gE C-MN) and powder-attached microneedles (gE P-MN)—for painless, skin-targeted pediatric vaccination.</p><p>Immunogenicity assessments in boosted BALB/c mice revealed comparable IgG antibody titers (&gt; 15 log₂) induced by gE P-MN, gE C-MN, and traditional intramuscular injection, indicating equivalent efficacy among delivery methods. Both MN formulation maintained antigen integrity during fabrication and exhibited excellent long-term stability at 25&#xa0;°C over 12 months, with gE P-MN showing slightly superior stability compared to gE C-MN. Notably, both MN types significantly outperformed a liquid vaccine formulation in stability. Ex vivo porcine skin studies confirmed high intradermal delivery efficiency (&gt; 95%) for both microneedle types. Additionally, both platforms demonstrated no skin irritation or pyrogenic effects in rabbit safety models.</p><p>These findings demonstrate that powder-attached and coated microneedles effectively deliver recombinant VZV gE vaccines, satisfying essential requirements for pediatric immunization, including immunogenicity, storage stability, and safety. Thus, recombinant VZV gE microneedles represent a promising, user-friendly vaccine platform capable of enhancing compliance and vaccine accessibility, particularly in resource-limited regions.​.</p> Graphical abstract <p></p>

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Development and evaluation of recombinant Varicella-Zoster virus glycoprotein E protein microneedles for enhanced pediatric vaccine delivery

  • 期刊论文

  • 发表日期：

    2025年11月11日

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  • Da-Eun Lee,
  • Hye-Ran Cha,
  • Ye-Lim Lee,
  • Hyeon Woo Chung,
  • Sunghoon Park,
  • Yu-Jeong Oh,
  • Eunjung Jung,
  • Seung-Ki Baek,
  • Byung Cheol Ahn,
  • Jung Sun Yum,
  • Jae Myun Lee,
  • Jung-Hwan Park

摘要

Varicella-zoster virus (VZV) infection remains a significant pediatric health concern, and current live-attenuated vaccines are limited by cold-chain requirements, reactivation risk, and injection-related anxiety. To address these challenges, we developed and evaluated two recombinant VZV glycoprotein E (gE) microneedle (MN) platforms—coated microneedles (gE C-MN) and powder-attached microneedles (gE P-MN)—for painless, skin-targeted pediatric vaccination.

Immunogenicity assessments in boosted BALB/c mice revealed comparable IgG antibody titers (> 15 log₂) induced by gE P-MN, gE C-MN, and traditional intramuscular injection, indicating equivalent efficacy among delivery methods. Both MN formulation maintained antigen integrity during fabrication and exhibited excellent long-term stability at 25 °C over 12 months, with gE P-MN showing slightly superior stability compared to gE C-MN. Notably, both MN types significantly outperformed a liquid vaccine formulation in stability. Ex vivo porcine skin studies confirmed high intradermal delivery efficiency (> 95%) for both microneedle types. Additionally, both platforms demonstrated no skin irritation or pyrogenic effects in rabbit safety models.

These findings demonstrate that powder-attached and coated microneedles effectively deliver recombinant VZV gE vaccines, satisfying essential requirements for pediatric immunization, including immunogenicity, storage stability, and safety. Thus, recombinant VZV gE microneedles represent a promising, user-friendly vaccine platform capable of enhancing compliance and vaccine accessibility, particularly in resource-limited regions.​.

Graphical abstract