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

BACKGROUND:Two 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...

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Bibliographic Details
Published in:PLOS Neglected Tropical Diseases
Main Authors: Anke Harenberg, Aymeric de Montfort, Frédérique Jantet-Blaudez, Matthew Bonaparte, Florence Boudet, Melanie Saville, Nicholas Jackson, Bruno Guy
Format: Article in Journal/Newspaper
Language:English
Published: Public Library of Science (PLoS) 2016
Subjects:
Online Access:https://doi.org/10.1371/journal.pntd.0004830
https://doaj.org/article/ca06e209e1fd4560b77f9a3fb56471c0
Description
Summary:BACKGROUND:Two 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 FINDINGS:We 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.