title: Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials.
abstract: 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).
  
  
  
  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.
  
  
  
  These exploratory findings show that CYD-TDV does not induce a particular immune profile versus placebo, corroborating the clinical profile observed.
authors.affiliation: R&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
authors.forename: Anke
authors.initials: A
authors.lastname: Harenberg
authors.affiliation: R&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
authors.forename: Aymeric
authors.initials: A
authors.lastname: de Montfort
authors.affiliation: R&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Jantet-Blaudez
authors.affiliation: Global Clinical Immunology Department, Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bonaparte
authors.affiliation: R&NCS Department, Sanofi Pasteur, Marcy l'Etoile, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Boudet
authors.affiliation: Global Clinical Development, Sanofi Pasteur, Marcy l'Etoile, Lyon, France.
authors.forename: Melanie
authors.initials: M
authors.lastname: Saville
authors.affiliation: Research and Development, Sanofi Pasteur, Lyon, France.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Jackson
authors.affiliation: Research and Development, Sanofi Pasteur, Lyon, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Guy
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D016207:Cytokines / Q000097:blood*; D003715:Dengue / Q000097:blood / Q000276:immunology / Q000628:therapy* / Q000821:virology; D053059:Dengue Vaccines / Q000008:administration & dosage* / Q000276:immunology; D003716:Dengue Virus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D008297:Male; D014613:Vaccines, Attenuated / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D016207:Cytokines; D053059:Dengue Vaccines; D014613:Vaccines, Attenuated