Abstract
A new live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) has been developed based on innovative technology to give protection against JE with an improved immunogenicity and safety profile. In this phase 3, observer-blind study, 274 children aged 12−24 months were randomized 1:1 to receive one dose of JE-CV (Group JE-CV) or the SA14–14–2 vaccine currently used to vaccinate against JE in the Republic of Korea (Group SA14–14–2). JE neutralizing antibody titers were assessed using PRNT50 before and 28 days after vaccination. The primary endpoint of non-inferiority of seroconversion rates on D28 was demonstrated in the Per Protocol analysis set as the difference between Group JE-CV and Group SA14–14–2 was 0.9 percentage points (95% confidence interval [CI]: −2.35; 4.68), which was above the required −10%. Seroconversion and seroprotection rates 28 days after administration of a single vaccine dose were 100% in Group JE-CV and 99.1% in Group SA14–14–2; all children except one (Group SA14–14–2) were seroprotected. Geometric mean titers (GMTs) increased in both groups from D0 to D28; GM of titer ratios were slightly higher in Group JE-CV (182 [95% CI: 131; 251]) than Group SA14–14–2 (116 [95% CI: 85.5, 157]). A single dose of JE-CV was well tolerated and no safety concerns were identified. In conclusion, a single dose of JE-CV or SA14–14–2 vaccine elicited a comparable immune response with a good safety profile. Results obtained in healthy Korean children aged 12−24 months vaccinated with JE-CV are consistent with those obtained in previous studies conducted with JE-CV in toddlers.
Highlights
Japanese encephalitis (JE) is a mosquito-borne, vaccine preventable viral disease that is seasonally endemic or epidemic in nearly every country in Asia.[1,2] JE virus (JEV) is the most important cause of viral encephalitis in Asia.[3]
As the JE vaccine is generally preferred to be given in Spring and Summer, children were recruited in two cohorts (July to December 2011 and May to September 2012)
Children 6–59 mo of age are the priority target group for influenza vaccination and are recommended to be vaccinated annually in Korea
Summary
Japanese encephalitis (JE) is a mosquito-borne, vaccine preventable viral disease that is seasonally endemic or epidemic in nearly every country in Asia.[1,2] JE virus (JEV) is the most important cause of viral encephalitis in Asia.[3] JEV is estimated to be responsible for at least 50,000 cases of clinically manifest disease per year, mostly among children aged less than 10 y, and is recognized as a significant cause of childhood morbidity and mortality. The moral rights of the named author(s) have been asserted
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