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

Sanofi

Status: Completed

Conditions: Dengue Fever; Dengue Haemorrhagic Fever

Study type: Observational

Funder types: Industry

Identifiers

NCT02827162

CYD59

U1111-1127-7875 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject currently enrolled in, or having recently finished, CYD57 (NCT01983553; long-term safety follow-up study of the first PoC efficacy study), included in the subjects list provided by the Sponsor, with or without past experience of virologically confirmed dengue.
• For children 7 to < 18 years. Assent form (AF) has been signed and dated by the subject, and informed consent form (ICF) has been signed and dated by the parents or another legally acceptable representative and by independent witness, as per local Ethics Committee (EC) requirement. For subjects ≥ 18 years. ICF has been signed and dated by the subject and by independent witness, as per local EC requirement.
• Subject (and parent(s) / legally acceptable representative for subject < 18 years) are able to attend the scheduled visit and can comply with all study procedures.

Exclusion criteria

• Any illness that, in the opinion of the Investigator, might interfere with study procedures.

Trial design

334 participants in 4 patient groups

Case D1

Description:

Subject having experienced a Virologically confirmed dengue infection, from the first injection until the end of the active phase, excluding Case D3 subjects

Case D3

Description:

Subject having experienced a Virologically confirmed dengue infection, from 28 days after the third injection until the end of the Active Phase of the proof of concept (PoC) efficacy study

Control I

Description:

Subject having not experienced a Virologically confirmed dengue infection in the Active Phase of the PoC efficacy study, and belonging to the PoC efficacy study immunogenicity subset

Control E

Description:

Subject having not experienced a Virologically confirmed dengue infection in the Active Phase of the PoC efficacy study, and not belonging to the PoC efficacy study immunogenicity subset