NCT02827162

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

Association of Host Genetics With Vaccine Efficacy, and Evaluation of Immune Correlates of Risk From the First Proof of Concept Efficacy Study With a Tetravalent Dengue Vaccine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 334 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Primary 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.

Detailed description

The enrolled population will include both, virologically-confirmed (VC) dengue cases and subjects not having experienced a VC dengue infection (control subjects) from the first Proof of Concept efficacy study conducted in Thailand Analyses for correlates will be performed on samples collected in the context of the first proof of concept efficacy study. Sequencing of dengue viruses will also be done on samples collected within the same context. Immunogenetic testing will be performed on saliva samples collected at the study enrollment visit. No intervention or vaccine will be provided or administered as part of this study.

Conditions

• Dengue Fever
• Dengue Haemorrhagic Fever

Timeline

• Start date: 2016-03-29
• Primary completion: 2016-04-27
• Completion: 2016-04-27
• First posted: 2016-07-11
• Last updated: 2022-04-25

Locations

1 site across 1 country: Thailand