Li Yuhua, Jia Zheng, Wu Xiaohong, Wang Ling, Chen Lei, Dai Xinxian, Li Xiuling, Wang Junzhi
National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China; State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, and Collaborative Innovation Center for Biotherapy, Chengdu, 610041, China.
National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China.
Biologicals. 2019 Sep;61:68-75. doi: 10.1016/j.biologicals.2019.05.007. Epub 2019 Jul 27.
Severe fever with thrombocytopenia syndrome (SFTS) is an acute infectious disease caused by severe fever with thrombocytopenia syndrome virus (SFTSV). SFTS is mainly characterized by severe fever with thrombocytopenia and has a high mortality rate. The virus has been found in China, South Korea, and Japan. Effective antiviral drugs or vaccines still have been unavailable. Now, two vaccine manufacturers in China are actively engaged in the development of the vaccine. To promote the development of SFTS vaccines and ensure their effective quality control, we developed national antigen and antibody references. We collaborative calibrated the standards; evaluated the homogeneity and stability of the national SFTS standards. The national SFTS vaccine antigen and antibody references met the Chinese national standards and can be used to standardize quality control for the manufacture of SFTS vaccines. And also can be used into the study the dose-response relationship of SFTS vaccines, determine clinical doses, and evaluate vaccine immunogenicity.
发热伴血小板减少综合征（SFTS）是由发热伴血小板减少综合征病毒（SFTSV）引起的一种急性传染病。SFTS主要以发热伴血小板减少为特征，且死亡率较高。该病毒已在中国、韩国和日本被发现。目前仍没有有效的抗病毒药物或疫苗。现在，中国的两家疫苗生产商正在积极开展该疫苗的研发工作。为推动SFTS疫苗的研发并确保其有效的质量控制，我们研制了国家抗原和抗体标准品。我们协同校准了这些标准品；评估了国家SFTS标准品的均匀性和稳定性。国家SFTS疫苗抗原和抗体标准品符合中国国家标准，可用于规范SFTS疫苗生产的质量控制。还可用于研究SFTS疫苗的剂量反应关系、确定临床剂量以及评估疫苗免疫原性。
