title: A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea.
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.
authors.affiliation: a Yonsei University College of Medicine; Severance Children's Hospital ; Seoul , Korea.
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Kim
authors.forename: Guy
authors.initials: G
authors.lastname: Houillon
authors.forename: Gwang Cheon
authors.initials: GC
authors.lastname: Jang
authors.forename: Sung-Ho
authors.initials: SH
authors.lastname: Cha
authors.forename: Soo-Han
authors.initials: SH
authors.lastname: Choi
authors.forename: Jin
authors.initials: J
authors.lastname: Lee
authors.forename: Hwang Min
authors.initials: HM
authors.lastname: Kim
authors.forename: Ji Hong
authors.initials: JH
authors.lastname: Kim
authors.forename: Jin Han
authors.initials: JH
authors.lastname: Kang
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Ki Hwan
authors.initials: KH
authors.lastname: Kim
authors.forename: Hee Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Joon
authors.initials: J
authors.lastname: Bang
authors.forename: Zulaikha
authors.initials: Z
authors.lastname: Naimi
authors.forename: Valérie
authors.initials: V
authors.lastname: Bosch-Castells
authors.forename: Mark
authors.initials: M
authors.lastname: Boaz
authors.forename: Alain
authors.initials: A
authors.lastname: Bouckenooghe
mesh_terms: D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D004672:Encephalitis, Japanese / Q000276:immunology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D008297:Male; D056910:Republic of Korea; D016037:Single-Blind Method; D016896:Treatment Outcome; D014611:Vaccination / Q000009:adverse effects / Q000379:methods*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D014614:Vaccines, Synthetic
keywords: AE, adverse event; AESI, AE of Special Interest; AR, adverse reaction; CI, confidence interval; FAS, Full Analysis Set; GMT, Geometric mean titers; GMTRs, GM of titer ratios; JE, Japanese encephalitis; JE-CV, JE chimeric virus vaccine; JEV, JE virus; Japanese encephalitis (JE) vaccine; MBDV, mouse brain derived inactivated anti-JE vaccines; PP, Per Protocol; PRNT50, 50% plaque reduction neutralization test; Phase 3 trial; SAE, serious adverse events.; children; immunogenicity; safety