Evidence map›Paper›PMID 27459266›Full record

Trial reportPLoS neglected tropical diseases2016

Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials.

Anke Harenberg, Aymeric de Montfort, Frédérique Jantet-Blaudez, Matthew Bonaparte, Florence Boudet, Melanie Saville, Nicholas Jackson, Bruno Guy

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

Trial report in PLoS neglected tropical diseases, 2016. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

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
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 18 citations in OpenAlex.

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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

8 authors at 2 institutions in 2 countries.

Anke HarenbergR&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
Aymeric de MontfortR&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
Frédérique Jantet-BlaudezR&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
Matthew BonaparteGlobal Clinical Immunology Department, Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.
Florence BoudetR&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
Melanie SavilleGlobal Clinical Development, Sanofi Pasteur, Marcy l'Etoile, Lyon, France.
Nicholas JacksonResearch and Development, Sanofi Pasteur, Lyon, France.
Bruno GuyResearch and Development, Sanofi Pasteur, Lyon, France.
Sanofi (France) · FRSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTwo large-scale efficacy studies with the recombinant yellow fever-17D-dengue virus, live-attenuated, tetravalent dengue vaccine (CYD-TDV) candidate undertaken in Asia (NCT01373281) and Latin America (NCT01374516) demonstrated significant protection against dengue disease during two years' active surveillance (active phase). Long-term follow up of participants for breakthrough disease leading to hospitalization is currently ongoing (hospital phase). METHODOLOGY/PRINCIPAL

findingsWe assessed the cytokine profile in acute sera from selected participants hospitalized (including during the active phase) up to the beginning of the second year of long-term follow up for both studies. The serum concentrations of 38 cytokines were measured in duplicate using the Milliplex Human Cytokine MAGNETIC BEAD Premixed 38 Plex commercial kit (Millipore, Billerica, MA, USA). Partial least squares discriminant analyses did not reveal any difference in the overall cytokine profile of CYD-TDV and placebo recipients hospitalized for breakthrough dengue regardless of stratification used. In addition, there was no difference in the cytokine profile for breakthrough dengue among those aged <9 years versus those aged ≥ 9 years. CONCLUSIONS/SIGNIFICANCE: These exploratory findings show that CYD-TDV does not induce a particular immune profile versus placebo, corroborating the clinical profile observed.

Indexed as

AdolescentAntibodies, ViralChildChild, PreschoolCytokinesDengueDengue VaccinesDengue VirusFemaleHospitalizationHumansInfantMaleVaccines, AttenuatedAntibodies, ViralCytokinesDengue VaccinesVaccines, Attenuated

Identifiers

PMID27459266
PMCPMC4961416
OpenAlexW2496176096

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.