Briggs Deborah J, Moore Susan M
Department of Diagnostic Medicine/Pathobiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS 66506, USA.
Viruses. 2021 Jun 27;13(7):1252. doi: 10.3390/v13071252.
Cell culture rabies vaccines were initially licensed in the 1980s and are essential in the prevention of human rabies. The first post-exposure prophylaxis (PEP) vaccination regimen recommended by the World Health Organization (WHO) was administered intramuscularly over a lengthy three-month period. In efforts to reduce the cost of PEP without impinging on safety, additional research on two strategies was encouraged by the WHO including the development of less expensive production methods for CCVs and the administration of reduced volumes of CCVs via the intradermal (ID) route. Numerous clinical trials have provided sufficient data to support a reduction in the number of doses, a shorter timeline required for PEP, and the approval of the intradermal route of administration for PEP and pre-exposure prophylaxis (PreP). However, the plethora of data that have been published since the development of CCVs can be overwhelming for public health officials wishing to review and make a decision as to the most appropriate PEP and PreP regimen for their region. In this review, we examine three critical benchmarks that can serve as guidance for health officials when reviewing data to implement new PEP and PreP regimens for their region including: evidence of immunogenicity after vaccination; proof of efficacy against development of disease; and confirmation that the regimen being considered elicits a rapid anamnestic response after booster vaccination.
细胞培养狂犬病疫苗最初于20世纪80年代获得许可,对预防人类狂犬病至关重要。世界卫生组织(WHO)推荐的首个暴露后预防(PEP)疫苗接种方案是在长达三个月的时间内进行肌肉注射。为了在不影响安全性的情况下降低PEP成本,WHO鼓励对两种策略开展更多研究,包括开发成本更低的细胞培养狂犬病疫苗(CCV)生产方法以及通过皮内(ID)途径减少CCV接种量。众多临床试验提供了充分的数据,支持减少剂量数量、缩短PEP所需时间,并批准将皮内途径用于PEP和暴露前预防(PreP)。然而,自CCV研发以来发表的数据过多,对于希望审查并决定其所在地区最适合的PEP和PreP方案的公共卫生官员来说,可能会应接不暇。在本综述中,我们审视了三个关键基准,可为卫生官员在审查数据以在其所在地区实施新的PEP和PreP方案时提供指导,包括:接种疫苗后的免疫原性证据;预防疾病发生的有效性证明;以及确认所考虑的方案在加强免疫后能引发快速的回忆反应。