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News

Enterovirus 71 vaccine provides protection against EV71-associated hand, foot, and mouth disease

A publication in this week's issue of the New England Journal of Medicine evaluates the efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.

News image

Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide.

This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine.

Dr Fengcai Zhu and colleagues from China conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children were randomly assigned in a 1:1 ratio to receive 2 intramuscular doses of either EV71 vaccine or placebo, 28 days apart.

The surveillance period was 12 months.

The team's primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina.

Vaccine efficacies against EV71-associated hospitalization was 100%
New England Journal of Medicine

During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients, and 2.1% of placebo recipients in the intention-to-treat cohort.

The team found that this vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 95% in this cohort.

Vaccine efficacies against EV71-associated hospitalization and hand, foot, and mouth disease with neurologic complications were both 100%.

The team observed that serious adverse events occurred in about 2% of children in the vaccine group, and about 3% of children in the placebo group.

In the immunogenicity subgroup, an anti-EV71 immune response was elicited by the 2-dose vaccine series in 99% of participants at day 56.

The researchers observed that an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina.

Dr Zhu and team comment, "The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. "

N Engl J Med 2014; 370:818-828
28 February 2014

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