Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia (DENWOLUTION)
Primary Purpose
Arbovirus Infections, Dengue, Zika
Status
Recruiting
Phase
Locations
France
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Arbovirus Infections focused on measuring New Caledonia
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier TerritorialRecruiting
Outcomes
Primary Outcome Measures
arbovirus genome sequencing
Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024
genetic evolution of arbovirus strains
bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024
Secondary Outcome Measures
measurement of the impact of Wolbachia on the virus genetic evolution
comparison of viral genomes extracted from blood samples collected from 1995 to 2024
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
Full Information
NCT ID
NCT04615364
First Posted
October 29, 2020
Last Updated
October 6, 2022
Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
1. Study Identification
Unique Protocol Identification Number
NCT04615364
Brief Title
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
Acronym
DENWOLUTION
Official Title
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
Study Type
Observational
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
July 17, 2025 (Anticipated)
Study Completion Date
July 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arbovirus Infections, Dengue, Zika, Chikungunya
Keywords
New Caledonia
7. Study Design
Enrollment
600 (Anticipated)
Primary Outcome Measure Information:
Title
arbovirus genome sequencing
Description
Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024
Time Frame
5 years
Title
genetic evolution of arbovirus strains
Description
bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024
Time Frame
5 years
Secondary Outcome Measure Information:
Title
measurement of the impact of Wolbachia on the virus genetic evolution
Description
comparison of viral genomes extracted from blood samples collected from 1995 to 2024
Time Frame
5 years
Title
measurement of the ability of these viruses to replicate in the presence of Wolbachia
Description
infection of cell lines with virus strains isolated and amplified from patient blood samples collected from 1995 to 2024
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Study Population Description
Patient infected by arboviruses
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myrielle Dupont-Rouzeyrol, PhD
Phone
+687 27 75 30
Email
mdupont@pasteur.nc
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Inizan, PhD
Phone
+687 27 26 66
Email
cinizan@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrielle Dupont-Rouzeyrol, PhD
Organizational Affiliation
Institut Pasteur de Nouvelle-Calédonie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Territorial
City
Dumbéa Sur Mer
State/Province
Nouvelle-Calédonie
ZIP/Postal Code
98 835
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann-Claire Gourinat, MD
Phone
+687 208000
Email
ann-claire.gourinat@cht.nc
12. IPD Sharing Statement
Citations:
PubMed Identifier
33686914
Citation
Inizan C, Minier M, Prot M, O'Connor O, Forfait C, Laumond S, Marois I, Biron A, Gourinat AC, Goujart MA, Descloux E, Sakuntabhai A, Tarantola A, Simon-Loriere E, Dupont-Rouzeyrol M. Viral evolution sustains a dengue outbreak of enhanced severity. Emerg Microbes Infect. 2021 Dec;10(1):536-544. doi: 10.1080/22221751.2021.1899057.
Results Reference
derived
Learn more about this trial
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
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