Trial reportHuman vaccines & immunotherapeutics2016
Validation and evaluation of serological correlates of protection for inactivated enterovirus 71 vaccine in children aged 6-35 months.
Trial report in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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.
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Who cites it
12 citing papers in PubMed, 27 citations in OpenAlex.
- A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial.Human vaccines & immunotherapeutics · 2022Trial
- Estimating the Severity Profile of Enterovirus A71 Infections in Children: A Bayesian Synthesis Framework.American journal of epidemiology · 2019Trial
- Genistein inhibits the replication of enterovirus A71.Frontiers in pharmacology · 2026Article
- Improving precision of vaccine efficacy evaluation using immune correlate data in time-to-event models.NPJ vaccines · 2024Article
- Humoral and cellular immunogenicity and efficacy of a coxsackievirus A10 vaccine in mice.Emerging microbes & infections · 2023Article
- Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need.Signal transduction and targeted therapy · 2021Review
- Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination.Human vaccines & immunotherapeutics · 2020Article
- Development of a pseudovirus-based assay for measuring neutralizing antibodies against Coxsackievirus A10.Human vaccines & immunotherapeutics · 2020Article
- A surrogate assay for measuring Coxsackievirus A6 neutralizing antibodies.Human vaccines & immunotherapeutics · 2018Article
- Identification of immune correlates of protection in Shigella infection by application of machine learning.Journal of biomedical informatics · 2017Article
- Development of a pseudovirus based assay for measuring neutralizing antibodies against coxsackievirus B5.Journal of virological methods · 2017Article
- Rheum emodin inhibits enterovirus 71 viral replication and affects the host cell cycle environment.Acta pharmacologica Sinica · 2017Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA primary goal of this study was to establish the serological mechanistic correlate of protection (mCoP) for an inactivated Enterovirus 71 (EV71) vaccine.
methodsWe used the Prentice criterion framework and scaled logit model to explore the relationship between the neutralizing antibody (NTAb) and EV71-associated disease, and to build a protection curve for estimating the efficacy of EV71 vaccine. Data of NTAb at day 56 post-vaccination and the occurrence of EV71-associated disease during a 12-month follow-up period were collected from a phase 3 efficacy trial of EV71 vaccine in this study.
resultsNTAb at day 56 post-vaccination in participants met the Prentice criterion framework. According to the protection curve, the antibody levels of 14.7, 27.8, 55.7, 129.0 and 459.4 (U/mL) were associated with 50%, 60%, 70%, 80% and 90% clinical protection rate, respectively. Vaccine efficacy predicted by the model was 81.5%, which was very similar to the actual vaccine efficacy of 80.4% (95% CI, 58.2, 90.8) observed in the phase 3 trial.
conclusionsNTAb titers post-vaccination can be validated as mCoP for evaluating the efficacy of an inactivated enterovirus 71 vaccine, with a titers of 14.7 (U/ml) as a surrogate associated with the protection of 50% against EV71-associated disease.
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