Cordeiro Ana Sara, Patil-Sen Yogita, Shivkumar Maitreyi, Patel Ronak, Khedr Abdulwahhab, Elsawy Mohamed A
Leicester Institute for Pharmaceutical Innovation, Leicester School of Pharmacy, De Montfort University, Leicester LE1 9BH, UK.
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, National Health Service, Wigan WN6 0SZ, UK.
Pharmaceutics. 2021 Dec 5;13(12):2091. doi: 10.3390/pharmaceutics13122091.
Viral infections causing pandemics and chronic diseases are the main culprits implicated in devastating global clinical and socioeconomic impacts, as clearly manifested during the current COVID-19 pandemic. Immunoprophylaxis via mass immunisation with vaccines has been shown to be an efficient strategy to control such viral infections, with the successful and recently accelerated development of different types of vaccines, thanks to the advanced biotechnological techniques involved in the upstream and downstream processing of these products. However, there is still much work to be done for the improvement of efficacy and safety when it comes to the choice of delivery systems, formulations, dosage form and route of administration, which are not only crucial for immunisation effectiveness, but also for vaccine stability, dose frequency, patient convenience and logistics for mass immunisation. In this review, we discuss the main vaccine delivery systems and associated challenges, as well as the recent success in developing nanomaterials-based and advanced delivery systems to tackle these challenges. Manufacturing and regulatory requirements for the development of these systems for successful clinical and marketing authorisation were also considered. Here, we comprehensively review nanovaccines from development to clinical application, which will be relevant to vaccine developers, regulators, and clinicians.
引发大流行和慢性病的病毒感染是造成全球严重临床和社会经济影响的主要罪魁祸首，正如当前新冠疫情期间所明显表现的那样。通过大规模接种疫苗进行免疫预防已被证明是控制此类病毒感染的有效策略，由于这些产品上下游加工过程中涉及先进的生物技术，不同类型的疫苗得以成功研发且近期研发进程加速。然而，在递送系统、制剂、剂型和给药途径的选择方面，在提高疗效和安全性方面仍有许多工作要做，这些不仅对免疫效果至关重要，而且对疫苗稳定性、给药频率、患者便利性以及大规模免疫接种的物流也很关键。在这篇综述中，我们讨论了主要的疫苗递送系统及相关挑战，以及近期在开发基于纳米材料的先进递送系统以应对这些挑战方面所取得的成功。还考虑了这些系统成功进行临床和上市许可开发的制造和监管要求。在此，我们全面综述从研发到临床应用的纳米疫苗，这将对疫苗开发者、监管者和临床医生具有参考价值。
