Workshop Report on Global Harmonization of Enterovirus Vaccines

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Volume 26, Number 4—April 2020

Conference Summary

Tzu-Yu Weng, Hua Yen, Kutub Mahmood, Javier Martin, and Min-Shi Lee

National Health Research Institutes, Zhunan, Taiwan (T.-Y. Weng, H. Yen, M.-S. Lee)Center for Vaccine Innovation and Access, PATH, Seattle, Washington, USA (K. Mahmood)National Institute for Biological Standard and Control, Potters Bar, UK (J. Martin)

The Asia-Pacific Network for Enterovirus Surveillance in the National Health Research Institutes hosted a workshop on May 2, 2019, to discuss the harmonization of 2 licensed enterovirus vaccines, poliovirus and enterovirus A71 (EV-A71), especially regarding the standardization of vaccine antigens (Appendix). Speakers from the UK National Institute for Biologic Standard and Control (NIBSC), US PATH, industries, and regulatory agencies shared their experiences.

Sabin strain–derived live-attenuated oral poliovirus vaccines (OPV) and wild strain–derived inactivated poliovirus vaccines (IPV) have been widely used. Since wild-type 2 poliovirus was eradicated, bivalent OPV (only type 1 and 3) replaced trivalent OPV. Wild-type 3 is almost eradicated, and major efforts are under way to eradicate type 1. In addition, wild strains are not feasible to produce conventional IPV (cIPV) after wild polioviruses are eradicated. Therefore, the World Health Organization (WHO) recommends the development of Sabin strain–derived IPV (sIPV) for the endgame plan of global poliovirus eradication programs. Because WHO international standard (IS) antigen for quantifying cIPV antigens could not be effectively used to quantify sIPV, new reagents based on sIPV need to be established.

Three EV-A71 vaccines have been licensed in China, and 2 EV-A71 vaccine candidates were evaluated in phase III trials in Taiwan. Experience with IPV indicates that establishing WHO IS antigens is critical for global harmonization of EV-A71 vaccines. Thus, NIBSC and the China National Institute of Food and Drug Control (NIFDC) coordinated an international study for the first IS antigen of EV-A71 vaccines. Some participants in the international study shared their results in the workshop. This report summarizes outcomes of presentations and discussion.

https://wwwnc.cdc.gov/eid/article/26/4/19-1273_article

【CANCELLED】19TH INTERNATIONAL CONGRESS ON INFECTIOUS DISEASES

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Due to the unfolding COVID-19 pandemic and the safety concerns surrounding mass gatherings, the organizers of the 19th International Congress on Infectious Diseases (ICID) have made the difficult decision to cancel the Congress scheduled for September 10-13, 2020 in Kuala Lumpur, Malaysia.

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 A71 (EV-A71), enterovirus D68 (EV-D68), and several echoviruses (Echo) and cox-sackieviruses (CV). Especially, EV-A71 has repeatedly caused large-scale outbreaks in the Asia-Pacificregion since 1997. Some Asian countries have experienced cyclical outbreaks of severe EV-A71 infectionsand initiated development of EV-A71 vaccines. Five EV-A71 vaccine candidates have been clinically eval-uated and three of them were approved for marketing in China.

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 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to (<)two years received a booster dose at one year after the first dose. During the surveillance period, solicited adverse events (AEs) and unsolicited AEs were recorded for safety evaluation. Blood samples were collected for neutralising antibody assay at various times. Immune persistence and booster effects were also assessed.

Results: A total of 363 children completed the study. Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly. Most participants in the vaccine groups achieved defined seroprotection (neutralization titre  1:32) after the second vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could provide a cross-reaction against other EV-A71 strain geno-types: B5, C4a, C4b, and C5.

Conclusions: The mid dose of the EV-A71 vaccine elicited high immune response and were tolerable in participants aged between two months and 11 years in all dosing groups.

Sourced from Medigen Vaccine Corporation, Taiwan

The Research Institute for Tropical Medicine, Philippines

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The Research Institute for Tropical Medicine (RITM) had its humble beginnings soon after the culmination of over a decade of negotiations between the governments of the Philippines and Japan for the establishment of a tropical medicine research center. RITM was tasked to plan and implement research programs for infectious and tropical diseases.

The original building facilities of RITM, which included a laboratory wing and a 50-bed hospital for patients with infectious diseases requiring tertiary care, were inaugurated on April 23, 1981.

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Happy Holidays from APNES!

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APNES team would like to wish you a happy and healthy holiday season, and a happy New Year!