带状疱疹预防用疫苗临床评价的考虑

Considerations for clinical evaluation of herpes zoster preventive vaccines

带状疱疹及其并发症带状疱疹后神经痛严重影响患者生活质量,给社会带来显著的疾病负担。目前尚无治疗带状疱疹的特效药物,接种疫苗仍然是预防带状疱疹及其并发症的最佳方式。我国尚无国产带状疱疹预防用疫苗上市,仍具有未被满足的市场需求。本文将结合疫苗临床试验的一般技术要求,同时考虑国内正在研发的带状疱疹预防用疫苗的分类及特点,分析和总结此类疫苗临床评价中应重点考虑的内容,供国内临床研发人员参考。

Herpes zoster and its complications postherpetic neuralgia seriously affects the quality of life for patients,and brings significant disease burden to the society.At present,since there is no effective drug for the treatment of herpes zoster,vaccination is still the best approach to prevent herpes zoster and its complications.There is no domestic herpes zoster preventive vaccine authorized in China until now,so there is still unmet demands from market.Combined with the general technical requirements by clinical trials of vaccine,considering classification and characteristics of herpes zoster preventive vaccines in China,the key points that should be considered in clinical evaluation of herpes zoster preventive vaccine will be analyzed and summarized in this article,so as to provide references for domestic clinical trials and studies.