PDF(Pubmed)
Abstract：
The recent centennial anniversary of R.E. Montgomery\'s seminal published description of \"a form of swine fever\" disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (MLV) first-generation gene deleted vaccine candidates currently offer the most promise to meet international and national guidelines and regulatory requirements for veterinary product licensure and market authorization. A major, rate-limiting impediment to the acceleration of current as well as future vaccine candidates into regulatory development is the absence of internationally harmonized standards for assessing vaccine purity, potency, safety, and efficacy. This review summarizes the asymmetrical landscape of peer-reviewed published literature on ASF MLV vaccine approaches and lead candidates, primarily studied to date in the research laboratory in proof-of-concept or early feasibility clinical safety and efficacy studies. Initial recommendations are offered toward eventual consensus of international harmonized guidelines and standards for ASF MLV vaccine purity, potency, safety, and efficacy. To help ensure the successful regulatory development and approval of ASF MLV first generation vaccines by national regulatory associated government agencies, the World Organisation for Animal Health (WOAH) establishment and publication of harmonized international guidelines is paramount.
摘要：
最近，R.E.Montgomery发表的关于“一种形式的猪瘟”疾病从非洲野猪传播到欧洲家猪的开创性描述是加速非洲猪瘟（ASF）疫苗研发的行动呼吁。目前，ASF修饰的活病毒（MLV）第一代基因缺失的候选疫苗最有希望满足国际和国家指南以及兽医产品许可和市场授权的监管要求。一个少校,目前和未来的候选疫苗加速进入监管发展的限速障碍是缺乏评估疫苗纯度的国际统一标准，效力，效力安全,和功效。这篇综述总结了关于ASFMLV疫苗方法和候选药物的同行评审已发表文献的不对称景观。迄今为止，主要在研究实验室进行了概念验证或早期可行性临床安全性和有效性研究。针对ASFMLV疫苗纯度的国际协调指南和标准的最终共识提供了初步建议。效力，效力安全,和功效。为了帮助确保成功的监管开发和国家监管相关政府机构批准ASFMLV第一代疫苗，世界动物卫生组织（WOAH）建立和发布统一的国际准则至关重要。
