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

Background: To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was 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. = 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 genotypes: 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. (C) 2019 Elsevier Ltd. All rights reserved.