Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia

Dengue Clinical Trial

— DENWOLUTION  

Official title:

Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615364
• Other study ID #: 2019-022
• Status: Recruiting
• Start date: July 17, 2020
• Est. completion date: July 17, 2025

Study information

• Verified date: May 2024
• Source: Institut Pasteur
• Contact: Myrielle Dupont-Rouzeyrol, PhD
• Phone: +687 27 75 30
• Email: mdupont[@]pasteur.nc
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, especially in tropical and sub-tropical countries. A promising strategy aimed at blocking the circulation of arboviruses is to release Aedes aegypti mosquitoes carrying the endosymbiotic bacterium Wolbachia. In 2019, the Wolbachia strategy was implemented in Nouméa as part of the World Mosquito Program. This intervention will modify the epidemiological profile of arboviruses in New Caledonia.

Epidemiological surveillance of arboviruses requires molecular characterization of the virus contained in the serum obtained from the blood collected from patients. This molecular characterization by RNA isolation techniques, RT-qPCR monitoring and sequencing allows the construction of phylogenetic trees.

In the context of the implementation of the World Mosquito Program in Nouméa, the investigators plan to follow the molecular evolution of arboviruses, over the period preceding the releases of mosquitoes carrying Wolbachia (from 1995 to 2019) then over a period of 5 years. following the releases.

At the same time, the virus can be isolated by cell culture techniques and in vitro infections, allowing its study in vitro in cells or in vivo in mosquitoes. This study allows us to measure the impact of the Wolbachia strategy on the evolution of the virus's ability to replicate in cells in the presence of Wolbachia and to be transmitted by the mosquito.

Description:

Collection of blood samples from patients with arbovirus infection

This study is a non-interventional study with retrospective part.

This study will improve :

• the assessment of the molecular evolution of arboviruses in the period preceding the implementation of the Wolbachia strategy

• the knowledge of the impact of Wolbachia on the diversity and molecular evolution of arboviruses

• the understanding of arbovirus transmission and replication mechanisms in the presence of Wolbachia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 17, 2025
• Est. primary completion date: July 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Appearance of clinical signs suggestive of an infection with an arbovirus in the 7 days preceding the blood sample,

• Diagnostic confirmation by RT-qPCR of mono-infection with dengue virus or another arbovirus.

• Patients or their representative (s) informed of the possible secondary use for research purposes of the samples initially taken for diagnostic purposes and their derivatives, and who have not since expressed their opposition to the secondary use of the samples diagnostics or their derivatives for research,

Exclusion Criteria:

• Documented opposition from a patient or his representative (s)

• Previously established viral load too low.

• Sample obtained from a sample taken more than 7 days after the appearance of clinical signs of infection.

Related Conditions & MeSH terms

• Arbovirus Infections
• Chikungunya
• Dengue
• Zika

Locations

Country	Name	City	State
France	Centre Hospitalier Territorial	Dumbéa Sur Mer	Nouvelle-Calédonie

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	Centre Hospitalier Territorial de Nouvelle-Calédonie, Institut Pasteur de Nouvelle-Calédonie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arbovirus genome sequencing	Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024	5 years
Primary	genetic evolution of arbovirus strains	bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024	5 years
Secondary	measurement of the impact of Wolbachia on the virus genetic evolution	comparison of viral genomes extracted from blood samples collected from 1995 to 2024	5 years
Secondary	measurement of the ability of these viruses to replicate in the presence of Wolbachia	infection of cell lines with virus strains isolated and amplified from patient blood samples collected from 1995 to 2024	5 years