Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Disease burden of enterovirus 71 in rural central China: A community-based survey

“…Three biological product companies have completed the phase III clinical trial of EV71 inactivated vaccine and the results show that the vaccine is safe and effective. 23,32,33 Our findings suggest that more financial resources should be invested toward the prevention and management of EV71-associated disease, especially the severe HFMD. The department of health administration and government should reduce the disease burden of patients through various measures such as improving medical cost reimbursement, optimizing methods for diagnosis or treatment of EV71-associated disease.…”

“…At present, the study of EV71 mainly focused on the investigation of outbreak, 19 the analysis of severe cases, 20 the surveillance of molecular epidemiology, 21 and the evaluation of EV71 vaccine efficacy. 22,23 This study, based on 2 large-scale phase 3 clinical trials of an inactivated EV71 vaccine, we estimated the economic and health burden of EV71 associated-disease using the TAPQOL questionnaire to provide valuable information for both those researching the cost-effectiveness analysis of EV71 vaccine and those who make policies regarding the plan or allocation of health resources.…”

“…23,33 The surveillance and definition of EV71-associated disease was referred to in these trials. We investigated 343 cases due to EV71 infection, which were reported between 2011 and 2013 by the Ganyu and Sheyang prefecture Centers for Disease Control and Prevention.…”

How to understand the efficacy measurements for enterovirus type 71 vaccine?

“…15 Therefore, in order to avoid missed EV71-associated cases, the active surveillance system we built in the efficacy trial covered all possible cases with suspected clinical symptoms without an obvious cause, by excluding only those with a definite other cause such as burning, traffic accident and so on. 14 However, several other pathogens can also cause the abovementioned clinical manifestations. Even for HFMD which is often considered as the most typical disease caused by EV71, it can be clinically indistinguishable from HFMD cases caused by other enteroviruses such as Coxsackievirus A16 (CA16), CA4, CA5, CA6, CA7, CA9, CA10, and echoviruses 1, 4, 11, 18, and EV18.…”

“…The trial was the first in which the efficacy of this novel vaccine was demonstrated. 14 In the trial, both EV71-associated HFMD and EV71-associated disease (including EV71-associated HFMDs and other EV71-associated other cases) were considered as primary endpoint. To identify cases and exclude non-cases is, usually, challenging in vaccine efficacy study.…”