Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China

Abstract

The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).

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.…”

“…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.…”

Polioviruses and other Enteroviruses

“…However efforts have been initiated to develop a vaccine against specific EVs most notably EV-71 (Liang and Wang, 2014;Lu, 2014;Zhu et al, 2014). …”

Validation and evaluation of serological correlates of protection for inactivated enterovirus 71 vaccine in children aged 6-35 months

“…8,9 Currently, 3 inactivated EV71 vaccines developed in China have demonstrated good efficacy and safety profile in the phase 3 clinical trials. [10][11][12] These 3 EV71 vaccines are very likely to be the first available vaccines against EV71-associated disease in the world.…”

“…In two of the 3 trials, 10,12 correlate of immunity againstEV71-associated disease was explored by applying a receiver operating characteristics (ROC) curve analysis in a subset of cohort selected by matching each case with 5 controls. The results suggested that antibody titers of 1:16-1:32 with the maximum Youden index might be a possible serologic marker for protection against EV71-associated disease.…”