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Tytuł:
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Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of SFTS vaccines.
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Autorzy:
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Li Y; 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.
Jia Z; National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China.
Wu X; National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China.
Wang L; National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China.
Chen L; Beijing Institute of Biological Products Co., Ltd., Beijing, 101111, PR China.
Dai X; Beijing Institute of Biological Products Co., Ltd., Beijing, 101111, PR China.
Li X; Beijing Institute of Biological Products Co., Ltd., Beijing, 101111, PR China.
Wang J; National Institutes for Food and Drug Control, No. 31. Huatuo Road, Daxing District, Beijing, 102629, PR China. Electronic address: .
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Źródło:
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Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2019 Sep; Vol. 61, pp. 68-75. Date of Electronic Publication: 2019 Jul 27.
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Typ publikacji:
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Evaluation Study; Journal Article
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Język:
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English
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Imprint Name(s):
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Original Publication: London ; San Diego : Academic Press, c1990-
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MeSH Terms:
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Viral Vaccines*/immunology
Viral Vaccines*/standards
Antibodies, Neutralizing/*immunology
Antibodies, Viral/*immunology
Antigens, Viral/*immunology
Bunyaviridae Infections/*immunology
Phlebovirus/*immunology
Animals ; Bunyaviridae Infections/prevention & control ; China ; Chlorocebus aethiops ; Humans ; Reference Standards ; Vero Cells
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Contributed Indexing:
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Keywords: Antigen; Neutralizing antibody; Severe fever with thrombocytopenia syndrome vaccine; Standard
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Substance Nomenclature:
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0 (Antibodies, Neutralizing)
0 (Antibodies, Viral)
0 (Antigens, Viral)
0 (Viral Vaccines)
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Entry Date(s):
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Date Created: 20190731 Date Completed: 20200205 Latest Revision: 20200205
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Update Code:
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20240105
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DOI:
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10.1016/j.biologicals.2019.05.007
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PMID:
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31358411
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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.
(Copyright © 2019. Published by Elsevier Ltd.)
