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Association of Host Genetics With Vaccine Efficacy and Study of Immune Correlates of Risk From a Tetravalent Dengue Vaccine

Ensayo de Sanofi en Dengue Fever · Dengue Haemorrhagic Fever (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

334

previstos

Centros

1

Fin del objetivo primario

abr 2016

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en mar 2016.

Qué mide

Number of Symptomatic Virologically confirmed dengue cases having occurred during the Active Phase of the first proof of concept efficacy study after post dose 1 (28 days post-injection 1 up to 4 years (the end of the Active phase)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objectives: * To assess how dengue vaccine efficacy varies across participant subgroups regarding polymorphism in human leukocyte antigen (HLA) alleles of interest. * To assess the association between HLA alleles and, serotype-specific neutralization antibody titers and summary neutralization measure in the vaccine and placebo groups. * To assess the association between the polymorphism in HLA alleles of interest and susceptibility to Dengue fever and Dengue Haemorrhagic fever. Secondary objectives: * To assess whether dengue serotype-specific neutralizing antibody titers and associated summary neutralization measure at 28 days post-dose 3 are related to the rate of occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3 * To evaluate whether the dengue serotype-specific neutralizing antibody and associated summary neutralization measure at 28 days post-dose 3 are related to the level of vaccine efficacy against dengue viruses after post-dose 3.

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Ficha completa en ClinicalTrials.gov (NCT02827162), actualizada en abr 2022.