Alternatives to syringe-based administration are considered for vaccines. Intradermal vaccination with dissolvable microneedle arrays (MNA) appears promising in this respect, as an easy-to-use and painless method. In this work, we have developed an MNA patch (MNAP) made of hydroxyethyl starch (HES) and chondroitin sulphate (CS). In swines, hepatitis B surface antigen (HBsAg) formulated with the saponin QS-21 as adjuvant, both incorporated in HES-based MNAP, demonstrated the same level of immunogenicity as a commercially available aluminum-adjuvanted HBsAg vaccine, after two immunizations 28 days apart. MNAP application was associated with transient skin reactions (erythema, lump, scab), particularly evident when the antigen was delivered with the adjuvant. The thermostability of the adjuvanted antigen when incorporated in the HES-based matrix was also assessed by storing MNAP at 37, 45 or 50 °C for up to 6 months. We could demonstrate that antigenicity was retained at 37 and 45 °C and only a 10% loss was observed after 6 months at 50 °C. Our results are supportive of MNAP as an attractive alternative to classical syringe-based vaccination.

中文翻译：

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可溶性微针阵列贴片中掺入的乙型肝炎表面抗原具有抗原性和热稳定性

对于疫苗，可以考虑使用基于注射器的替代方法。在这方面，作为一种易于使用且无痛的方法，用可溶性微针阵列（MNA）进行皮内疫苗接种似乎很有希望。在这项工作中，我们开发了由羟乙基淀粉（HES）和硫酸软骨素（CS）制成的MNA贴片（MNAP）。在猪中，以皂苷QS-21作为佐剂配制的乙型肝炎表面抗原（HBsAg），都掺入了基于HES的MNAP中，在两次免疫间隔28天后，表现出与市售的铝佐剂HBsAg疫苗相同的免疫原性水平。 。MNAP的应用与短暂的皮肤反应（红斑，肿块，结ab）有关，当抗原与佐剂一起递送时尤其明显。当掺入基于HES的基质中时，还可以通过将MNAP在37、45或50°C下保存长达6个月来评估佐剂抗原的热稳定性。我们可以证明抗原性在37和45°C下保持不变，并且在50°C下放置6个月后仅观察到10％的损失。我们的研究结果支持MNAP作为基于传统注射器的疫苗接种的一种有吸引力的替代方法。