Two-year efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine against hand, foot and mouth disease in children

Abstract

Objectives: To evaluate the efficacy and immunogenicity of the Sinovac Enterovirus 71 (EV71) vaccine for up to two years.

Methods: We did a follow-up study of our initial randomized trial in 10,077 participants, who were randomized to receive EV71 vaccine or placebo in a 1:1 ratio and followed for 14 months. The extended follow-up study lasted for another 12 months and EV71-associated hand, foot, and mouth disease (HFMD) was the primary endpoint.

Results: The EV71 vaccine showed an efficacy of 95.1% (95%CI 63.6, 99.3) against EV71-associated HFMD during the extended follow-up and an overall efficacy of 94.7% (95%CI 87.8, 97.6) for two years. The EV71 vaccine elicited a sustained high level of neutralizing antibodies in participants, and no serious adverse event was judged to be related to the vaccination.

Conclusion: The Sinovac EV71 vaccine could provide a sustained high protection against EV71-associated HFMDs for up to 2 years.

Keywords: Sinovac Enterovirus 71 vaccine; efficacy; hand, foot, and mouth disease; immunogenicity; safety.