Evidence map›Paper›PMID 25483480›Full record

Trial reportHuman vaccines & immunotherapeutics2014

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 and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Safety of Japanese encephalitis vaccines.Human vaccines & immunotherapeutics · 2021
    Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Japanese Encephalitis Vaccines.Current treatment options in infectious diseases · 2020
    Review
  13. Review
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 11 institutions in 4 countries.

Dong Soo Kima Yonsei University College of Medicine; Severance Children's Hospital ; Seoul , Korea.
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 Boaz
Alain Bouckenooghe
Sanofi (Mexico) · MXKorea Electric Power Corporation (South Korea) · KRSanofi (France) · FRYonsei University · KRGangnam Severance Hospital · KRKyung Hee University · KRNational Health Insurance Service Ilsan Hospital · KRSeverance Hospital · KRSwift Engineering (United States) · USThe Catholic University of Korea Seoul St. Mary's Hospital · KRThe Catholic University of Korea St. Vincent's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Antibodies, NeutralizingAntibodies, ViralChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsEncephalitis, JapaneseFemaleHumansInfantJapanese Encephalitis VaccinesMaleRepublic of KoreaSingle-Blind MethodTreatment OutcomeVaccinationVaccines, SyntheticAntibodies, NeutralizingAntibodies, ViralJapanese Encephalitis VaccinesVaccines, SyntheticAE, adverse eventAESI, AE of Special InterestAR, adverse reactionchildrenCI, confidence intervalFAS, Full Analysis SetGMT, Geometric mean titersGMTRs, GM of titer ratiosimmunogenicityJapanese encephalitis (JE) vaccineJE-CV, JE chimeric virus vaccineJE, Japanese encephalitisJEV, JE virusMBDV, mouse brain derived inactivated anti-JE vaccinesPhase 3 trialPP, Per ProtocolPRNT50, 50% plaque reduction neutralization testSAE, serious adverse events.safety

Identifiers

PMID25483480
PMCPMC4977450
OpenAlexW1987172583

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.