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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

 Dong Soo Kim  ;  Guy Houillon  ;  Gwang Cheon Jang  ;  Sung-Ho Cha  ;  Soo-Han Choi  ;  Jin Lee  ;  Hwang Min Kim  ;  Ji Hong Kim  ;  Jin Han Kang  ;  Jong-Hyun Kim  ;  Ki Hwan Kim  ;  Hee Soo Kim  ;  Joon Bang  ;  Zulaikha Naimi  ;  Valérie Bosch-Castells  ;  Mark Boazl  ;  Alain Bouckenooghe 
Journal Title
Issue Date
Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Child ; Child, Preschool ; Drug-Related Side Effects and Adverse Reactions ; Encephalitis, Japanese/immunology ; Encephalitis, Japanese/prevention & control* ; Female ; Humans ; Infant ; Japanese Encephalitis Vaccines/administration & dosage ; Japanese Encephalitis Vaccines/adverse effects ; Japanese Encephalitis Vaccines/genetics ; Japanese Encephalitis Vaccines/immunology* ; Male ; Republic of Korea ; Single-Blind Method ; Treatment Outcome ; Vaccination/adverse effects ; Vaccination/methods* ; Vaccines, Synthetic/administration & dosage ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/genetics ; Vaccines, Synthetic/immunology
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
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.
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1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Ki Hwan(김기환)
Kim, Dong Soo(김동수)
Kim, Ji Hong(김지홍) ORCID logo https://orcid.org/0000-0001-5352-5423
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