Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines |
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Authors: | Liang Zhenglun Mao Qunying Gao Qiang Li Xiuling Dong Chenghong Yu Xiang Yao Xin Li Fengxiang Yin Weidong Li Qihan Shen Xinliang Wang Junzhi |
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Institution: | a National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, PR China b Sinovac Biotech Co., Ltd., Beijing 100085, PR China c National Vaccine & Serum Institute, Beijing 100024, PR China d Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming 650118, PR China e Hualan Biological Engineering Inc., Henan 453003, PR China |
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Abstract: | Enterovirus 71 (EV71) is a highly infectious agent that causes hand-foot-mouth disease (HFMD) in humans. Effective vaccination against EV71 infection is critically important, given the recent outbreak of HFMD in the Asia-Pacific region, where it has shown significant mortality and morbidity. There is currently no approved anti-viral therapy available to treat the disease. While several vaccine manufacturers are actively developing EV71 vaccines, there are no international reference standards available to conduct quality control on EV71 vaccines or to assess the effectiveness of EV71 vaccines in immunized populations. In the current report, antigen reference standard based on the C4 subtype of the EV71 vaccine strain was developed. In addition, neutralizing antibody (NTAb) reference panels were analyzed and standards with various neutralizing titers were selected. These reference antigens were used to calibrate vaccine samples from several producers and found that five EV71 antigens and the national reference standards showed good linearity and parallelism. Moreover, mice immunized with various vaccines at doses standardized by these national references showed comparable NTAb responses. Finally, the national NTAb reference panels were found to effectively reduce assay discrepancy between different labs. Taken together, these national reference standards are highly valuable for the standardization and evaluation of EV71 vaccines. |
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Keywords: | Enterovirus 71 (EV71) Vaccine Antigen Neutralizing antibody (NTAb) |
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