- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615364
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia (DENWOLUTION)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Myrielle Dupont-Rouzeyrol, PhD
- Phone Number: +687 27 75 30
- Email: mdupont@pasteur.nc
Study Locations
-
-
Nouvelle-Calédonie
-
Dumbéa Sur Mer, Nouvelle-Calédonie, France, 98 835
- Recruiting
- Centre Hospitalier Territorial
-
Contact:
- Ann-Claire Gourinat, MD
- Phone Number: +687 208000
- Email: ann-claire.gourinat@cht.nc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
arbovirus genome sequencing
Time Frame: 5 years
|
Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024
|
5 years
|
genetic evolution of arbovirus strains
Time Frame: 5 years
|
bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of the impact of Wolbachia on the virus genetic evolution
Time Frame: 5 years
|
comparison of viral genomes extracted from blood samples collected from 1995 to 2024
|
5 years
|
measurement of the ability of these viruses to replicate in the presence of Wolbachia
Time Frame: 5 years
|
infection of cell lines with virus strains isolated and amplified from patient blood samples collected from 1995 to 2024
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Myrielle Dupont-Rouzeyrol, PhD, Institut Pasteur de Nouvelle-Calédonie
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arbovirus Infections
-
Institut PasteurCompleted
-
Institut PasteurInstitut Pasteur of New CaledoniaRecruiting
-
University of Notre DameUniversity of California, DavisCompleted
-
University of Notre DameUniversity of Washington; SC Johnson, A Family Company; fhiClinical; Ministry of... and other collaboratorsRecruitingArbovirus InfectionsSri Lanka
-
PATHInternational Centre for Diarrhoeal Disease Research, BangladeshCompleted
-
Bavarian NordicJPM CBRN MedicalCompletedEquine EncephalitisUnited States
-
London School of Hygiene and Tropical MedicineYunnan InstituteCompletedArbovirus Infections | Malaria
-
University of LiverpoolCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedJapanese EncephalitisKorea, Republic of
-
Sanofi Pasteur, a Sanofi CompanyCompletedJapanese EncephalitisKorea, Republic of