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

Sponsor
Institut Pasteur (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04615364
Collaborator
Institut Pasteur de Nouvelle-Calédonie (Other), Centre Hospitalier Territorial de Nouvelle-Calédonie (Other)
600
1
60
10

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Official Title:
    Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
    Actual Study Start Date :
    Jul 17, 2020
    Anticipated Primary Completion Date :
    Jul 17, 2025
    Anticipated Study Completion Date :
    Jul 17, 2025

    Outcome Measures

    Primary Outcome Measures

    1. arbovirus genome sequencing [5 years]

      Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024

    2. genetic evolution of arbovirus strains [5 years]

      bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024

    Secondary Outcome Measures

    1. measurement of the impact of Wolbachia on the virus genetic evolution [5 years]

      comparison of viral genomes extracted from blood samples collected from 1995 to 2024

    2. measurement of the ability of these viruses to replicate in the presence of Wolbachia [5 years]

      infection of cell lines with virus strains isolated and amplified from patient blood samples collected from 1995 to 2024

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Territorial Dumbéa Sur Mer Nouvelle-Calédonie France 98 835

    Sponsors and Collaborators

    • Institut Pasteur
    • Institut Pasteur de Nouvelle-Calédonie
    • Centre Hospitalier Territorial de Nouvelle-Calédonie

    Investigators

    • Principal Investigator: Myrielle Dupont-Rouzeyrol, PhD, Institut Pasteur de Nouvelle-Calédonie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Pasteur
    ClinicalTrials.gov Identifier:
    NCT04615364
    Other Study ID Numbers:
    • 2019-022
    First Posted:
    Nov 4, 2020
    Last Update Posted:
    Nov 6, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut Pasteur
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 6, 2020