Evidence map›Paper›PMID 23372725›Full record

Trial reportPloS one2013

Study of the integrated immune response induced by an inactivated EV71 vaccine.

Longding Liu, Ying Zhang, Jingjing Wang, Hongling Zhao, Li Jiang, Yanchun Che, Haijin Shi, Rongcheng Li, Zhaojun Mo, Teng Huang and 11 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 3% 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.

NCT01391494 phase1completednot on this map

A Phase I Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Adults, Children and Infants

TypeinterventionalSponsorInstitute of Medical Biology, Chinese Academy of Medical SciencesRan2011 to 2011Enrolled288ConditionsHand, Foot and Mouth DiseaseArms160Eu/0.5ml in adults, 320Eu/0.5ml in adults, 640Eu/0.5ml in adults, 1280Eu/0.5ml (without adjuvant) in 12 adults, 0Eu/0.5ml in adults
NCT01512706 phase2completednot on this map

A Phase II Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Infants

TypeinterventionalSponsorInstitute of Medical Biology, Chinese Academy of Medical SciencesRan2011 to 2012Enrolled660ConditionsThe Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and InfantsArms160Eu/0.5ml in infants (6-11 months old), 320Eu/0.5ml in infants (6-11 months old), 640Eu/0.5ml in infants (6-11 months old), 1280Eu/0.5ml (without adjuvant) in infants (6-11 months old), 0Eu/0.5ml in infants (6-11 months old)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  3. Trial
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  5. Trial
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  7. Article
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  11. A practical method for evaluating theEmerging microbes & infections · 2021
    Article
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  16. Review
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  19. Enterovirus 71 infection and vaccines.Clinical and experimental vaccine research · 2017
    Review
  20. Article
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

21 authors at 3 institutions in 2 countries.

Longding LiuInstitute of Medical Biology, Chinese Academy of Medicine Science, Peking Union Medical College, Kunming, People's Republic of China.
Ying Zhang
Jingjing Wang
Hongling Zhao
Li Jiang
Yanchun Che
Haijin Shi
Rongcheng Li
Zhaojun Mo
Teng Huang
Zhenglun Liang
Qunying Mao
Lichun Wang
Chenghong Dong
Yun Liao
Lei Guo
Erxia Yang
Jing Pu
Lei Yue
Zhenxin Zhou
Qihan Li
Chinese Academy of Medical Sciences & Peking Union Medical College · CNCenters for Disease Control and Prevention · USNational Institutes for Food and Drug Control · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledEnterovirus 71 (EV71), a major causative agent of hand-foot-and-mouth disease (HFMD), causes outbreaks among children in the Asia-Pacific region. A vaccine is urgently needed. Based on successful pre-clinical work, phase I and II clinical trials of an inactivated EV71 vaccine, which included the participants of 288 and 660 respectively, have been conducted. In the present study, the immune response and the correlated modulation of gene expression in the peripheral blood mononuclear cells (PBMCs) of 30 infants (6 to 11 months) immunized with this vaccine or placebo and consented to join this study in the phase II clinical trial were analyzed. The results showed significantly greater neutralizing antibody and specific T cell responses in vaccine group after two inoculations on days 0 and 28. Additionally, more than 600 functional genes that were up- or down-regulated in PBMCs were identified by the microarray assay, and these genes included 68 genes associated with the immune response in vaccine group. These results emphasize the gene expression profile of the immune system in response to an inactivated EV71 vaccine in humans and confirmed that such an immune response was generated as the result of the positive mobilization of the immune system. Furthermore, the immune response was not accompanied by the development of a remarkable inflammatory response. CLINICAL

trial registrationNCT01391494 and NCT01512706.

Indexed as

AnimalsAntibodies, NeutralizingAntibodies, ViralCytokinesDouble-Blind MethodEnterovirusGene Expression ProfilingGene Expression RegulationHand, Foot and Mouth DiseaseHumansImmunity, CellularInfantLeukocytes, MononuclearMicroarray AnalysisPlacebosVaccinationAntibodies, NeutralizingAntibodies, ViralCytokinesPlacebosVaccines, InactivatedViral Vaccines

Identifiers

PMID23372725
PMCPMC3553120
OpenAlexW2030086294

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.