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Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial

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dc.contributor.authorYun, Ki Wook-
dc.contributor.authorLee, Hoan Jong-
dc.contributor.authorKang, Jin Han-
dc.contributor.authorEun, Byung Wook-
dc.contributor.authorKim, Yae-Jean-
dc.contributor.authorKim, Kyung-Hyo-
dc.contributor.authorKim, Nam Hee-
dc.contributor.authorHong, Young Jin-
dc.contributor.authorKim, Dong Ho-
dc.contributor.authorKim, Hwang Min-
dc.contributor.authorCha, Sung-Ho-
dc.date.accessioned2015-02-16T01:33:52Z-
dc.date.available2015-02-16T01:33:52Z-
dc.date.issued2015-01-08-
dc.identifier.citationBMC Infectious Diseases. 15:7ko_KR
dc.identifier.urihttps://hdl.handle.net/10371/93790-
dc.description.abstractBackground: Although mouse brain-derived, inactivated Japanese encephalitis vaccines (JE-MBs) have been successfully used for a long time, potential rare neurological complications have prompted the development of a Vero cell culture-derived inactivated vaccine (JE-VC). In a phase III clinical study, we aimed to compare the safety and immunogenicity of a JE-VC, KD-287 with a JE-MB, JEV-GCC, in children.
Methods: In this multicenter, double-blinded, randomized controlled trial, the study population consisted of 205 healthy Korean children aged 12–23 months. Each subject was subcutaneously vaccinated with either KD-287 or JEV-GCC twice at an interval of 2 weeks and then vaccinated once 12 months after the second vaccination. Neutralizing antibodies were measured by the plaque reduction neutralization test using the homologous and heterologous, as a post hoc analysis, challenge virus strains.
Results: The three-dose regimen of KD-287 showed a comparable safety profile with JEV-GCC except higher incidence of fever after the first dose (30.4% and 14.7%, respectively). Most of the fever was mild degree (61.3% and 66.7%, respectively). KD-287 fulfilled the non-inferiority criteria for seroconversion rate (SCR) and geometric mean titer (GMT) of the neutralizing antibody, which were the primary endpoints, at 4 weeks after the third vaccination (95% CI: −1.00, 3.10 for the SCR difference and 10.8, 17.6 for the GMT ratio). The SCRs of KD-287 were all 100% and the GMTs were higher in the KD-287 group than in the JEV-GCC group after the second vaccination and before and after the third vaccination (GMT ratio: 5.59, 20.13, and 13.79, respectively, p < 0.001 in all). GMTs were higher in the KD-287 group in the heterologous analysis also (GMT ratio: 4.05, 5.15, and 4.19, respectively, p < 0.001 in all).
Conclusions: This study suggests that the KD-287, a JE-VC is as safe as and may be more effective than the licensed MB-derived vaccine. KD-287 could thus be useful as a second-generation vaccine and substitute for the current JE-MB vaccine in Korean children.
ko_KR
dc.language.isoenko_KR
dc.publisherBioMed Centralko_KR
dc.subjectJapanese encephalitisko_KR
dc.subjectVaccineko_KR
dc.subjectVero cellsko_KR
dc.subjectClinical trialko_KR
dc.titleSafety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trialko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor윤기욱-
dc.contributor.AlternativeAuthor이환종-
dc.contributor.AlternativeAuthor강진한-
dc.contributor.AlternativeAuthor은병욱-
dc.contributor.AlternativeAuthor김예진-
dc.contributor.AlternativeAuthor김경효-
dc.contributor.AlternativeAuthor김남희-
dc.contributor.AlternativeAuthor홍영진-
dc.contributor.AlternativeAuthor김동호-
dc.contributor.AlternativeAuthor김황민-
dc.contributor.AlternativeAuthor차성호-
dc.identifier.doi10.1186/s12879-014-0744-4-
dc.language.rfc3066en-
dc.description.versionPeer Reviewed-
dc.rights.holderKi Wook Yun et al.; licensee BioMed Central Ltd.-
dc.date.updated2015-01-16T12:15:52Z-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Pediatrics (소아과학전공)Journal Papers (저널논문_소아과학전공)
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