Trial reportBMC medicine2015
Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations.
Trial report in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01569581 (A Phase III Clinical Trial for Inactivated Enterovirus Type 71 Vaccine), which is not on this map. Cited by 25 papers.
What it found
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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.
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.
A Phase III Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Infants and Children
Who cites it
25 citing papers in PubMed, 42 citations in OpenAlex.
- Five-year immunity persistence following immunization with inactivated enterovirus 71 type (EV71) vaccine in healthy children: A further observation.Human vaccines & immunotherapeutics · 2018Trial
- Efficacy, Immunogenicity, and Safety of Enterovirus 71 Vaccines in Children: A Systematic Review and Meta-Analysis.Vaccines · 2026Review
- Enterovirus A71 priorities, challenges, and future opportunities in humoral immunity and vaccine development.NPJ vaccines · 2025Review
- Article
- Analysis of the Impact of Inactivated A71 Vaccine on the Incidence of Hand-Foot-Mouth Disease in Pudong New Area, Shanghai.Vaccines · 2024Article
- Sequence-specific nanoparticle barcode strategy for multiplex human enterovirus typing.Nature communications · 2024Article
- Article
- Neutralizing activity of intravenous immune globulin products against enterovirus D68 strains isolated in Japan.BMC infectious diseases · 2023Article
- A Bivalent Inactivated Vaccine Prevents Enterovirus 71 and Coxsackievirus A16 Infections in the Mongolian Gerbil.Biomolecules & therapeutics · 2023Article
- Article
- Effect of difference between EV-A71 virus epidemic strain and "vaccine strain" on neutralizing antibody titer.Human vaccines & immunotherapeutics · 2022Article
- Bioinformatics-based prediction of conformational epitopes for Enterovirus A71 and Coxsackievirus A16.Scientific reports · 2021Article
- Clinical, etiological and epidemiological investigations of hand, foot and mouth disease in southern Vietnam during 2015 - 2018.PLoS neglected tropical diseases · 2020Article
- Development and characterization of an enterovirus 71 (EV71) virus-like particles (VLPs) vaccine produced inHuman vaccines & immunotherapeutics · 2020Article
- Enterovirus 71 Infection Shapes Host T Cell Receptor Repertoire and Presumably Expands VP1-Specific TCRβ CDR3 Cluster.Pathogens (Basel, Switzerland) · 2020Article
- Neutralizing Antibodies against Enteroviruses in Patients with Hand, Foot and Mouth Disease.Emerging infectious diseases · 2020Article
- Scavenger receptor class a, member 3 is associated with severity of hand, foot, and mouth disease in a case-control study.Medicine · 2019Observational
- Advances in Antigenic Peptide-Based Vaccine and Neutralizing Antibodies against Viruses Causing Hand, Foot, and Mouth Disease.International journal of molecular sciences · 2019Review
- Epidemiology of Recurrent Hand, Foot and Mouth Disease, China, 2008-2015.Emerging infectious diseases · 2018Article
- Hand, foot and mouth disease: current knowledge on clinical manifestations, epidemiology, aetiology and prevention.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
34 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo investigate the long-term effects on immunity of an inactivated enterovirus 71 (EV71) vaccine and its protective efficacy.
methodsA sub-cohort of 1,100 volunteers from Guangxi Province in China was eligible for enrolment and randomly administered either the EV71 vaccine or a placebo on days 0 and 28 in a phase III clinical trial and then observed for the following 2 years with approval by an independent ethics committee of Guangxi Zhuang Autonomous Region, China. Serum samples from the 350 participants who provided a full series of blood samples (at all the sampling points) within the 2-year period were collected. Vaccine-induced immune effects, including the neutralizing antibody titres and cross-protection against different genotypes of EV71, were examined. This study also evaluated the protective efficacy of this vaccine based upon clinical diagnosis.
resultsThis sub-cohort showed a >60% drop-out rate over 2 years. The seroconversion rates among the 161 immunized subjects remained >95% at the end of study. The geometric mean titres of neutralizing antibodies (anti-genotype C4) 360 days after vaccination in 350 subjects were 81.0 (subjects aged 6-11 months), 98.4 (12-23 months), 95.0 (24-35 months), and 81.8 (36-71 months). These titres subsequently increased to 423.1, 659.0, 545.0, and 321.9, respectively, at 540 days post-immunization (d.p.i.), and similar levels were maintained at 720 d.p.i. Higher IFN-γ/IL-4-specific responses to the C4 genotype of EV71 and cross-neutralization reactivity against major EV71 genotype strains were observed in the vaccine group compared to those in the placebo group. Five EV71-infected subjects were observed in the placebo-treated control group and none in the vaccine-immunized group in per-protocol analysis.
conclusionThese results are consistent with the induction of dynamic immune responses and protective efficacy of the vaccine against most circulating EV71 strains. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT01569581, Trial registration date: March 2012.
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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.