Category Archives: Publications

Establishment of Asia-Pacific Network for Enterovirus Surveillance

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Conference Report Mu-Lin Chiu, Shu-Ting Luo, Ya-Yen Chen, Wan Yu Chung, Veasna Duong, Philippe Dussart, Yoke-Fun Chan, David Perera, Mong How Ooi, Nguyen Thi Thanh Thao, Huu Khanh Truong, Min-Shi Lee Abstract  Enteroviruses (EV), the major pathogens of hand, foot, and mouth disease (HFMD) and herpangina, affectmillions of children each year. Most human enteroviruses cause self-limited infections except polio-viruses, enterovirus… Read more »

Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan

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Li-Min Huang, Cheng-Hsun Chiu, Nan-Chang Chiu, Chien-Yu Lin, Ming-Ta Li, Tsun-Yung Kuo, Yi-Jen Weng, Erh-Fang Hsieh, I-Chen Tai abstract Background: To fight against enterovirus A71 (EV-A71)-associated diseases, initiated in Taiwan focusing on two-month-old infants. Methods: We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4… Read more »

Assay Development for Quantification of Enterovirus 71 Vaccine Antigens

Dr. Min-Shi Lee (李敏西) Investigator, Coordinator of Emerging Virus Program, National Institute of Infectious Diseases and Vaccinology (NIIDV), National Health Research Institutes (NHRI), Taiwan ABSTRACT Enterovirus 71 (EV71) and polioviruses both belong to enterovirus genus and could cause neurological infections. Based on phylogenetic analysis of VP1 genes, EV71 could be classified into three major genogroups (A, B and C), including… Read more »

Development of Standard Reagents for Harmonization of EV 71 Vaccines

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Dr. Javier Martin Principal Scientist Division of Virology, National Institute for Biological Standards and Control (NIBSC), United Kingdom ABSTRACT Enterovirus A71 (EV71) is the major causative agent of severe and fatal hand, foot and mouth (HFMD) disease. Since EV71 was first isolated from patients in California in 1969, it has been associated with sporadic cases and outbreaks of a wide… Read more »

Regulation of Vaccines in Malaysia

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Dr. Ramli Bin Zainal Director National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Malaysia ABSTRACT Vaccine approval process in Malaysia is regulated by the National Pharmaceutical Regulatory Agency (NPRA) which ensures the safety, effectiveness and availability of vaccines through its comprehensive regulatory review mechanisms. Premarketing approval stage Documentation requirements for product submission must adhere to the ASEAN Common Technical Dossier… Read more »

Regulation of Vaccine Development in Cambodia

Dr. Phat So Medical Doctor, Vice of Surveillance Bureau, Department of Communicable Disease Control, Ministry of Health, Cambodia ABSTRACT The National Immunization Program (NIP) established EPI in 1986 under the umbrella of Ministry of Health and the program was implemented throughout the country in 1988. The EPI comprises of BCG, HBV, OPV, DTP, HiB, PCV 13, IPV, MR and JE…. Read more »

Clinical Trial Review and Approval in Vietnam

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Dr. Trong Toan Nguyen Medical Doctor, Vice Deputy Department of Disease Control and Prevention, Pasteur Institute in Ho Chi Minh City, Vietnam Clinical trial activities in Vietnam are standardized since 2007 with the FDA collaboration in GCP training. Two years later, the EC-MOH was recognized by OHRP. WHO recognizes NRA to Vietnam since 07/2015 also. There are several regular, circular,… Read more »

Regulation of Vaccine Development in Taiwan

Dr. Mei-Fang Chen (陳美方) Senior Reviewer Division of Medicinal Products, Food and Drug Administration, Taiwan ABSTRACT In Taiwan, vaccine development, testing, and regulations follow a standard set of steps. First, it needs exploratory stage and preclinical stage to approve the safety and the desired immune response. After a successful Phase III trial, the vaccine developer will submit a NDA application… Read more »

Rapid Serotyping of Enterovirus Infections

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Dr. Yu-Chieh Liao (廖玉潔) Assistant Investigator Institute of Population Health Sciences, National Health Research Institutes, Taiwan ABSTRACT Human enteroviruses are currently classified into 4 species including more than 100 serotypes. There are about 10 serotypes frequently related to severe complications. Therefore, it is necessary to develop high-throughput diagnostic tools for rapid serotyping of enterovirus infections using clinical specimens, which could… Read more »

Rapid Diagnosis of EV71 Infections

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Dr. Jyh-Yuan Yang (楊志元) Head HIV & Viral Emerging Infection Disease Lab., Centers for Disease Control, Taiwan ABSTRACT EV71 infection has been associated with large outbreaks of HFMD and the majority of fatalities in Taiwan and other countries as well.  Rapid identification of the causative agent of HFMD, particularly whether there is EV71 infection, can help clinical management by focusing… Read more »