Evidence map›Paper›PMID 34219653›Full record

ArticleeLife2021

Efficacy profile of the CYD-TDV dengue vaccine revealed by Bayesian survival analysis of individual-level phase III data.

Daniel J Laydon, Ilaria Dorigatti, Wes R Hinsley, Gemma Nedjati-Gilani, Laurent Coudeville, Neil M Ferguson

3 registry-linked trialsAbstract read
In one paragraph

Article in eLife, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
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.

NCT01373281 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2017Enrolled10,275ConditionsDengue, Dengue Fever, Dengue Hemorrhagic FeverArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: Sodium chloride (NaCl) 0.9%
NCT01374516 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2018Enrolled20,869ConditionsDengue Fever, Dengue Hemorrhagic Fever, DengueArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: (NaCl) 0.9% solution
NCT06891950 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

Phase 3B, Double-blind, Randomized Study to Evaluate the Safety and Non-inferiority of the Humoral Immune Response of the Butantan Dengue Vaccine in Participants Aged 60 to 79 Years Compared to Participants Aged 40 to 59 Years

TypeinterventionalSponsorButantan InstituteRan2026 to 2027Enrolled997ConditionsDengueArmsDengue 1,2,3,4 (attenuated) vaccine
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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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

6 authors.

Daniel J LaydonMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.ORCID 0000-0003-4270-3321
Ilaria DorigattiMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.ORCID 0000-0001-9959-0706
Wes R HinsleyMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.
Gemma Nedjati-GilaniMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.
Laurent CoudevilleSanofi Pasteur, Lyon, France.
Neil M FergusonMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.

Funding

Department of Health PR-OD-1017-20002Medical Research Council MR/R015600/1Wellcome TrustWellcome Trust 213494/Z/18/Z
6 · The paper itself

Abstract

Background: Sanofi-Pasteur's CYD-TDV is the only licensed dengue vaccine. Two phase three trials showed higher efficacy in seropositive than seronegative recipients. Hospital follow-up revealed increased hospitalisation in 2-5- year-old vaccinees, where serostatus and age effects were unresolved. Methods: We fit a survival model to individual-level data from both trials, including year 1 of hospital follow-up. We determine efficacy by age, serostatus, serotype and severity, and examine efficacy duration and vaccine action mechanism. Results: Our modelling indicates that vaccine-induced immunity is long-lived in seropositive recipients, and therefore that vaccinating seropositives gives higher protection than two natural infections. Long-term increased hospitalisation risk outweighs short-lived immunity in seronegatives. Independently of serostatus, transient immunity increases with age, and is highest against serotype 4. Benefit is higher in seropositives, and risk enhancement is greater in seronegatives, against hospitalised disease than against febrile disease. Conclusions: Our results support vaccinating seropositives only. Rapid diagnostic tests would enable viable 'screen-then-vaccinate' programs. Since CYD-TDV acts as a silent infection, long-term safety of other vaccine candidates must be closely monitored. Funding: Bill & Melinda Gates Foundation, National Institute for Health Research, UK Medical Research Council, Wellcome Trust, Royal Society. Clinical trial number: NCT01373281 and NCT01374516.

Indexed as

Models, BiologicalAdolescentBayes TheoremChildChild, PreschoolDengueDengue VaccinesDengue VirusHumansSerogroupSurvival AnalysisDengue Vaccinesbayesian statisticsdengueepidemiologyglobal healthhumanmathematical modellingsurvival analysisvaccinevirus

Identifiers

PMID34219653
PMCPMC8321579

What OpenQuestion holds

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LicenceCC BY
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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.