title: Progress on the research and development of human enterovirus 71 (EV71) vaccines.
abstract: Enterovirus 71 (EV71) infections, which can cause severe complications, have become one of the serious public health issues in the Western Pacific region and China. To date, a number of pharmaceutical companies and institutes have initiated the research and development of EV71 vaccines as a countermeasure. As is the case with innovative vaccine development, there are several critical bottlenecks in EV71 vaccine development that must be overcome before the clinical trials, including the selection of vaccine strain, standardization of the procedure for quantifying neutralizing antibody (NTAb) and antigen, establishment and application of a reference standard and biological standards, development of animal models for the evaluation of protective efficacy, and identification of the target patient population. To tackle these technical obstacles, researchers in Mainland of China have conducted a series of studies concerning the screening of vaccine strains and the establishment of criteria, biological standards and detection methods, thereby advancing EV71 vaccine development. This review summarizes recent worldwide progress on the quality control and evaluation of EV71 vaccines.
authors.affiliation: National Institutes for Food and Drug Control, Beijing, 100050, China.
authors.forename: Zhenglun
authors.initials: Z
authors.lastname: Liang
authors.forename: Qunying
authors.initials: Q
authors.lastname: Mao
authors.forename: Fan
authors.initials: F
authors.lastname: Gao
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
mesh_terms: D057134:Antibodies, Neutralizing / Q000378:metabolism; D000956:Antigens, Viral / Q000378:metabolism; D004341:Drug Evaluation / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods; D029821:Enterovirus A, Human / Q000187:drug effects / Q000276:immunology; D004769:Enterovirus Infections / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006232:Hand, Foot and Mouth Disease / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D009500:Neutralization Tests / Q000379:methods; D012015:Reference Standards; D015164:Vaccines, Inactivated / Q000494:pharmacology; D014765:Viral Vaccines / Q000494:pharmacology / Q000592:standards
chemical_list: D057134:Antibodies, Neutralizing; D000956:Antigens, Viral; D015164:Vaccines, Inactivated; D014765:Viral Vaccines