School of Pharmacy, Aston University, Birmingham, UK.
AVaxziPen Limited, Milton Park, Abingdon, Oxfordshire, UK.
Expert Rev Vaccines. 2023 Jan-Dec;22(1):579-595. doi: 10.1080/14760584.2023.2229431.
With a limited global supply of vaccines and an increasing vaccine hesitancy, improving vaccination coverage has become a priority. Current vaccination regimes require multiple doses to be administered in a defined schedule where missed doses may lead to incomplete vaccine coverage and failure of immunization programmes. As such, there is an ever-increasing demand to convert multi-dose injectable vaccines into single-dose formats, often called single administration vaccines (SAVs).
This review summarizes recent developments in the field of SAVs, with a focus on pulsatile or controlled-release formulations. It will identify the technical challenges, translational as well as commercial barriers to SAVs development. Furthermore, the progress of SAV formulations for hepatitis B and polio vaccines will be reviewed thoroughly as case studies, with a focus on the development challenges and the preclinical immunogenicity/reactogenicity data.
Despite the efforts to develop SAVs, few attempts have advanced to Phase-I trials. Considering the SAV development journey and bottlenecks, including commercial barriers from the early stages, may overcome some of the hurdles around the technology. The renewed global focus on vaccines since the COVID-19 pandemic could facilitate development of a new generation of technologies for pandemic preparedness including strategies for SAVs.
随着疫苗全球供应有限和疫苗犹豫情绪不断增加,提高疫苗接种率已成为当务之急。目前的疫苗接种方案需要按照规定的时间表接种多剂疫苗,而错过的剂量可能导致疫苗接种不完全和免疫接种计划失败。因此,人们越来越需要将多剂量注射疫苗转换为单剂量剂型,通常称为单次给药疫苗(SAV)。
本综述总结了 SAV 领域的最新进展,重点关注脉冲或控制释放制剂。它将确定 SAV 开发面临的技术挑战、转化和商业障碍。此外,还将全面审查乙肝和脊髓灰质炎疫苗的 SAV 制剂作为案例研究,重点关注开发挑战和临床前免疫原性/反应原性数据。
尽管人们努力开发 SAV,但很少有尝试能进入 I 期临床试验。考虑到 SAV 的开发历程和瓶颈,包括早期的商业障碍,可能会克服该技术面临的一些障碍。自 COVID-19 大流行以来,全球对疫苗的重新关注可能会促进新一代疫苗的开发,包括为大流行做准备的技术,包括 SAV 策略。