(HealthDay News) – A vaccine for enterovirus 71 (EV71) has high efficacy for EV71-associated hand, foot, and mouth disease and EV71-associated disease, according to a study published online May 29 in The Lancet.
Feng-Cai Zhu, from the Jiangsu Provincial Center for Disease Control and Prevention in China, and colleagues examined the efficacy, safety, immunogenicity, antibody persistence, and immunological correlates of an inactivated alum-adjuvant EV71 vaccine in a randomized double-blind placebo-controlled phase 3 trial. Of the 10,245 enrolled participants, aged 6–35 months, 4,907 randomized to receive the vaccine and 4,939 randomized to receive placebo were included in the primary efficacy analysis.
The researchers found that the vaccine efficacy was 90% and 80.4% against EV71-associated hand, foot, and mouth disease and EV71-linked disease, respectively. Serious adverse events occurred in 1.2% and 1.5% of participants in the vaccine and placebo groups, respectively (P=0.27). Adverse events occurred in 71.2% and 70.3%, respectively (P=0.33).
“This exploratory analysis on the correlates of immunity is a substantial step forward; however, more evidence of its validity is needed,” the authors write.
Several authors disclosed financial ties to Beijing Vigoo Biological, which funded the study.