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Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of SFTS vaccines

Li, Yuhua, Jia, Zheng, Wu, Xiaohong, Wang, Ling, Chen, Lei, Dai, Xinxian, Li, Xiuling, Wang, Junzhi
Biologicals 2019
antigens, antiviral agents, calibration, dose response, fever, immunogenicity, infectious diseases, manufacturing, mortality, neutralizing antibodies, quality control, thrombocytopenia, vaccines, viruses, China, Japan, South Korea
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.